Please check on this at once as this effects your babies and children:
Nationwide Retail Recall of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, Due to Higher Concentration of Ibuprofen.
Monmouth Junction, NJ, Tris Pharma, Inc. is expanding the scope of its November 2018 recall by adding three (3) additional lots of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, to the retail (pharmacy) level. Some units from these batches have been found to have higher levels of Ibuprofen concentration.
Infants already susceptible to the adverse effects of ibuprofen may be at a slightly higher risk if they receive medication from an impacted bottle. There is a remote probability that infants, who may be more susceptible to a higher potency level of drug, may be more vulnerable to permanent NSAID-associated renal injury. Some units from these six (6) lots have been found to contain Ibuprofen as high as 10% above the specified limit. Studies have shown that safety issues or toxicity is generally accepted to be a concern in infants at doses in excess of 700% of the recommended dose.1 To date, no serious adverse events have been reported related to this recall.
The product is used as a pain reliever/fever reducer and is packaged in ? oz. and 1 oz. bottles. This voluntarily recall includes the six (6) lots listed below:
Lot No. NDC EXPIRATION DESCRIPTION COMPANY
4718 59779-925-23 12/19 CVS Health: Infants' Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 0.5 oz. bottle CVS Pharmacy
00717005A 49035-125-24 02/19 Equate: Infants' Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 1.0 oz. bottle Wal-Mart Stores Inc.
00717006A 59779-925-24
(Labeled as: 50428-1252-4)
02/19 CVS Health: Infants' Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 1.0 oz. bottle CVS Pharmacy
00717009A
(Previously announced) 49035-125-23 02/19 Equate: Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottle Wal-Mart Stores Inc
00717015A
(Previously announced) 49035-125-23 04/19 Equate: Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottle Wal-Mart Stores Inc
00717024A
(Previously announced) 49035-125-23 08/19 Equate: Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottle Wal-Mart Stores Inc
59779-925-23 CVS Health: Ibuprofen Oral Suspension Drops,
USP, 50 mg per 1.25 ml, in 0.5 oz. bottle CVS Pharmacy
55319-250-23 Family Wellness: Ibuprofen Oral Suspension Drops,
USP, 50 mg per 1.25 ml, in 0.5 oz. bottle Family Dollar Services Inc.
Tris Pharma, Inc. manufactures Ibuprofen Oral Suspension Drops, USP for a single customer, who markets and distributes the product to retailers. The retailers should stop further distribution of the affected lots, which are being recalled. Tris Pharma, Inc. has notified its customer by urgent recall notice and has arranged for the return of recalled products from retailers and distributors.
Consumers with questions regarding this recall may contact Tris Customer Service by 732-940-0358 (Monday through Friday, 8:00 AM ET- 5:00 PM PT) or via email at micc_tris@vigilarebp.com. Consumers, who may be concerned, should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Complete and submit the report Online: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA). The FDA has approved a class II retail level recall for this recall.
Showing posts with label recalls. Show all posts
Showing posts with label recalls. Show all posts
Thursday, January 31, 2019
Thursday, January 17, 2019
RXBAR Recalls Certain Varieties of Bars Due to a Potential Undeclared Peanut Allergen
For Immediate Release
RXBAR is voluntarily recalling certain varieties of bars because they may contain undeclared peanuts. People who have peanut allergies run the risk of serious or life-threatening allergic reaction if they consume this product.
Varieties being recalled are:
RXBAR: Apple Cinnamon, Blueberry, Chocolate Chip, Chocolate Hazelnut, Chocolate Sea Salt, Coconut Chocolate, Coffee Chocolate, Mango Pineapple, Maple Sea Salt, Mint Chocolate, Mixed Berry, Pumpkin Spice
RXBAR Kids: Apple Cinnamon Raisin, Berry Blast, Chocolate Chip
No other RXBAR flavors or RXBAR products are affected by the recall.
RXBAR identified the potential for peanut in two varieties - Chocolate Sea Salt and Coconut Chocolate - in December and initiated a recall of those varieties. We are expanding the recall out of an abundance of caution after recently receiving consumer contacts regarding allergic reactions to additional varieties.
Our investigation concluded that the issues stem from a specific ingredient supplied by a third party. We immediately changed suppliers for this ingredient when the issue arose.
People who have purchased affected product and who have peanut allergies should discard the product and contact their local retailer or RXBAR for replacement or a full refund. Consumers can contact the RXBAR consumer service team at info@rxbar.com or 1-312- 624-8200 Monday through Friday, 8:30am CT - 6pm CT and Saturday and Sunday 10am CT - 1pm CT.
Recalled products include:
Apple Cinnamon, single bar, UPC 57777 00417, 12-count carton, UPC 57777 00424Best By Dates between 4/16/2019 - 5/12/2019 and 7/10/2019 - 7/11/2019
Blueberry, single bar, UPC 57777 00419, 12-count carton, UPC 57777 00426 , 10-count carton, UPC 58030 00840, 5-count carton, UPC 58030 00843, 4-count carton, UPC 57777 00447Best By Dates between 3/21/2019 - 5/21/2019 and 7/7/2019 - 9/29/2019
Chocolate Chip, single bar, UPC 57777 00469, 12-count carton, UPC 57777 00472, 5-count carton, UPC 58030 00845, 4-count carton, UPC 57777 00492Best by Dates between 3/24/2019 - 5/14/2019, 7/11/2019 - 9/8/2019 and 9/30/2019 - 10/1/2019
Chocolate Hazelnut, single bar, UPC 59162 00709, 12-count carton, UPC 59162 00710, 4- count carton, UPC 59162 00717, Best By Dates between 2/17/2019 - 10/18/2019
Chocolate Sea Salt, single bar, UPC 57777 00423, 12-count carton, UPC 57777 00430, 10- count carton, UPC 59162 00720, 5-count carton, UPC 58030 00841, 4-count carton, UPC 57777 00448 Best By Dates between 3/4/2019 - 9/11/2019 and on 10/11/2019 only
Coconut Chocolate, single bar, UPC 57777 00421, 12-count carton, UPC 57777 00428, 5- count carton, UPC 58030 00844, 4-count carton, UPC 57777 00491 Best By Dates between 3/1/2019 - 10/13/2019
Coconut Chocolate, single bar, UPC 57777 00421, 12-count carton, UPC 57777 00428, 5- count carton, UPC 58030 00844, 4-count carton, UPC 57777 00491 Best By Dates between 3/1/2019 - 10/13/2019
Coffee Chocolate, single bar, UPC 57777 00422, 12-count carton, UPC 57777 00429, Best By Dates between 4/13/2019 - 8/15/2019
Mango Pineapple, single bar, UPC 57777 00494, 12-count carton, UPC 57777 00495, 4- count carton, UPC 59162 00718, Best By Dates between 2/16/2019 - 10/19/2019
Maple Sea Salt, single bar, UPC 57777 00441, 12-count carton, UPC 57777 00440, 4-count carton, UPC 57777 00454 Best By Dates between 3/2/2019 - 5/23/2019, 7/18/2019 - 7/19/2019 and 9/9/2019 - 9/10/2019
Mint Chocolate, single bar, UPC 57777 00433, 12-count carton, UPC 57777 00434, 4-count carton, UPC 57777 00449 Best By Dates between 3/2/2019 - 4/18/2019 and 7/26/2019 - 8/9/2019
Mixed Berry, single bar, UPC 57777 00467, 12-count carton, UPC 57777 00470, 4-count carton, UPC 59162 00700 Best By Dates between 3/14/2019 - 5/6/2019 and 7/10/2019 - 8/30/2019
KIDS Apple Cinnamon Raisin, single bar, UPC 57777 00477, 16-count carton, UPC 57777 00479, 5-count carton, UPC 57777 00453 Best By Dates between 3/3/2019 - 4/16/2019 and 7/12/2019 only
KIDS Berry Blast, single bar, UPC 57777 00475, 16-count carton, UPC 57777 00478, 5-count carton, UPC 57777 00451 Best By Dates between 3/14/2019 - 4/26/2019 and 6/6/2019 - 8/5/2019
KIDS Chocolate Chip, single bar, UPC 57777 00476, 16-count carton, UPC 57777 00480, 5- count carton, UPC 57777 00452, Best By Dates between 3/15/2019 - 4/14/2019 and 7/17/2019 - 9/21/2019
Pumpkin Spice, single bar, UPC 57777 00418, 12-count carton, UPC 57777 00425, 4-count carton, UPC 59162 00719 Best By Dates between 5/9/2019 - 7/11/2019
10-Bar Variety Pack (Blueberry, Chocolate Sea Salt, Coconut Chocolate, Peanut Butter Chocolate), UPC 59162 00725, Best By Dates between 1/14/2019 - 10/16/2019
12-Bar Variety Pack (Chocolate Sea Salt, Peanut Butter Chocolate), UPC 57777 00481Best By Dates between 1/14/2019 - 6/10/2019
12-Bar Variety Pack (Blueberry, Chocolate Sea Salt, Mixed Berry, Peanut Butter, Peanut Butter Chocolate), UPC 57777 00435, See Best By Date on individual bars as noted in other 12-bar pack
14-Bar Variety Pack (Chocolate Chip and Chocolate Sea Salt), UPC 58030 00821, Best By Dates between 9/20/2019 - 10/1/2019
16-Bar Variety Pack (Chocolate Sea Salt, Peanut Butter Chocolate), UPC 59162 00784, Best By Dates between 7/18/2019 - 9/7/2019
Product images of these products can be found at www.rxbar.com/recall
RXBAR is voluntarily recalling certain varieties of bars because they may contain undeclared peanuts. People who have peanut allergies run the risk of serious or life-threatening allergic reaction if they consume this product.
Varieties being recalled are:
RXBAR: Apple Cinnamon, Blueberry, Chocolate Chip, Chocolate Hazelnut, Chocolate Sea Salt, Coconut Chocolate, Coffee Chocolate, Mango Pineapple, Maple Sea Salt, Mint Chocolate, Mixed Berry, Pumpkin Spice
RXBAR Kids: Apple Cinnamon Raisin, Berry Blast, Chocolate Chip
No other RXBAR flavors or RXBAR products are affected by the recall.
RXBAR identified the potential for peanut in two varieties - Chocolate Sea Salt and Coconut Chocolate - in December and initiated a recall of those varieties. We are expanding the recall out of an abundance of caution after recently receiving consumer contacts regarding allergic reactions to additional varieties.
Our investigation concluded that the issues stem from a specific ingredient supplied by a third party. We immediately changed suppliers for this ingredient when the issue arose.
People who have purchased affected product and who have peanut allergies should discard the product and contact their local retailer or RXBAR for replacement or a full refund. Consumers can contact the RXBAR consumer service team at info@rxbar.com or 1-312- 624-8200 Monday through Friday, 8:30am CT - 6pm CT and Saturday and Sunday 10am CT - 1pm CT.
Recalled products include:
Apple Cinnamon, single bar, UPC 57777 00417, 12-count carton, UPC 57777 00424Best By Dates between 4/16/2019 - 5/12/2019 and 7/10/2019 - 7/11/2019
Blueberry, single bar, UPC 57777 00419, 12-count carton, UPC 57777 00426 , 10-count carton, UPC 58030 00840, 5-count carton, UPC 58030 00843, 4-count carton, UPC 57777 00447Best By Dates between 3/21/2019 - 5/21/2019 and 7/7/2019 - 9/29/2019
Chocolate Chip, single bar, UPC 57777 00469, 12-count carton, UPC 57777 00472, 5-count carton, UPC 58030 00845, 4-count carton, UPC 57777 00492Best by Dates between 3/24/2019 - 5/14/2019, 7/11/2019 - 9/8/2019 and 9/30/2019 - 10/1/2019
Chocolate Hazelnut, single bar, UPC 59162 00709, 12-count carton, UPC 59162 00710, 4- count carton, UPC 59162 00717, Best By Dates between 2/17/2019 - 10/18/2019
Chocolate Sea Salt, single bar, UPC 57777 00423, 12-count carton, UPC 57777 00430, 10- count carton, UPC 59162 00720, 5-count carton, UPC 58030 00841, 4-count carton, UPC 57777 00448 Best By Dates between 3/4/2019 - 9/11/2019 and on 10/11/2019 only
Coconut Chocolate, single bar, UPC 57777 00421, 12-count carton, UPC 57777 00428, 5- count carton, UPC 58030 00844, 4-count carton, UPC 57777 00491 Best By Dates between 3/1/2019 - 10/13/2019
Coconut Chocolate, single bar, UPC 57777 00421, 12-count carton, UPC 57777 00428, 5- count carton, UPC 58030 00844, 4-count carton, UPC 57777 00491 Best By Dates between 3/1/2019 - 10/13/2019
Coffee Chocolate, single bar, UPC 57777 00422, 12-count carton, UPC 57777 00429, Best By Dates between 4/13/2019 - 8/15/2019
Mango Pineapple, single bar, UPC 57777 00494, 12-count carton, UPC 57777 00495, 4- count carton, UPC 59162 00718, Best By Dates between 2/16/2019 - 10/19/2019
Maple Sea Salt, single bar, UPC 57777 00441, 12-count carton, UPC 57777 00440, 4-count carton, UPC 57777 00454 Best By Dates between 3/2/2019 - 5/23/2019, 7/18/2019 - 7/19/2019 and 9/9/2019 - 9/10/2019
Mint Chocolate, single bar, UPC 57777 00433, 12-count carton, UPC 57777 00434, 4-count carton, UPC 57777 00449 Best By Dates between 3/2/2019 - 4/18/2019 and 7/26/2019 - 8/9/2019
Mixed Berry, single bar, UPC 57777 00467, 12-count carton, UPC 57777 00470, 4-count carton, UPC 59162 00700 Best By Dates between 3/14/2019 - 5/6/2019 and 7/10/2019 - 8/30/2019
KIDS Apple Cinnamon Raisin, single bar, UPC 57777 00477, 16-count carton, UPC 57777 00479, 5-count carton, UPC 57777 00453 Best By Dates between 3/3/2019 - 4/16/2019 and 7/12/2019 only
KIDS Berry Blast, single bar, UPC 57777 00475, 16-count carton, UPC 57777 00478, 5-count carton, UPC 57777 00451 Best By Dates between 3/14/2019 - 4/26/2019 and 6/6/2019 - 8/5/2019
KIDS Chocolate Chip, single bar, UPC 57777 00476, 16-count carton, UPC 57777 00480, 5- count carton, UPC 57777 00452, Best By Dates between 3/15/2019 - 4/14/2019 and 7/17/2019 - 9/21/2019
Pumpkin Spice, single bar, UPC 57777 00418, 12-count carton, UPC 57777 00425, 4-count carton, UPC 59162 00719 Best By Dates between 5/9/2019 - 7/11/2019
10-Bar Variety Pack (Blueberry, Chocolate Sea Salt, Coconut Chocolate, Peanut Butter Chocolate), UPC 59162 00725, Best By Dates between 1/14/2019 - 10/16/2019
12-Bar Variety Pack (Chocolate Sea Salt, Peanut Butter Chocolate), UPC 57777 00481Best By Dates between 1/14/2019 - 6/10/2019
12-Bar Variety Pack (Blueberry, Chocolate Sea Salt, Mixed Berry, Peanut Butter, Peanut Butter Chocolate), UPC 57777 00435, See Best By Date on individual bars as noted in other 12-bar pack
14-Bar Variety Pack (Chocolate Chip and Chocolate Sea Salt), UPC 58030 00821, Best By Dates between 9/20/2019 - 10/1/2019
16-Bar Variety Pack (Chocolate Sea Salt, Peanut Butter Chocolate), UPC 59162 00784, Best By Dates between 7/18/2019 - 9/7/2019
Product images of these products can be found at www.rxbar.com/recall
Monday, January 7, 2019
Toyota is Recalling Toyota Tacoma Vehicles
Brake Master Cylinder Seal may be Damaged
Reduced brake performance can lengthen the distance needed to stop the vehicle, increasing the risk of a crash.
NHTSA Campaign Number:
18V888000
Manufacturer Toyota Motor Engineering & Manufacturing
Components SERVICE BRAKES, HYDRAULIC
Potential Number of Units Affected 44,121
Summary
Toyota Motor Engineering & Manufacturing (Toyota) is recalling certain 2018-2019 Toyota Tacoma vehicles.
Improper machining of the brake master cylinder may result in internal damage of one of the seals, affecting brake performance.
Remedy
Toyota will notify owners, and dealers will replace the brake master cylinder, free of charge. The recall is expected to begin January 21, 2019. Owners may contact Toyota customer service at 1-888-270-9371. Toyota's numbers for this recall are J16/J06.
Reduced brake performance can lengthen the distance needed to stop the vehicle, increasing the risk of a crash.
NHTSA Campaign Number:
18V888000
Manufacturer Toyota Motor Engineering & Manufacturing
Components SERVICE BRAKES, HYDRAULIC
Potential Number of Units Affected 44,121
Summary
Toyota Motor Engineering & Manufacturing (Toyota) is recalling certain 2018-2019 Toyota Tacoma vehicles.
Improper machining of the brake master cylinder may result in internal damage of one of the seals, affecting brake performance.
Remedy
Toyota will notify owners, and dealers will replace the brake master cylinder, free of charge. The recall is expected to begin January 21, 2019. Owners may contact Toyota customer service at 1-888-270-9371. Toyota's numbers for this recall are J16/J06.
Tuesday, January 1, 2019
Nationwide Recall of Blood Pressure Medication
This hits close to home as I must contact my pharmacy to see which lot was used to fill my Amlodipine and Valsarten for my own CHF and high blood pressure.
Aurobindo Pharma USA, Inc. Initiates Voluntary Nationwide Consumer Level Recall of 80 Lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP, Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity
For Immediate Release
December 31, 2018
Announcement
Aurobindo Pharma USA, Inc. is conducting a voluntary recall of 80 lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. The impurity detected in the finished drug product is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification. To date, Aurobindo Pharma USA, Inc. has not received any reports of adverse events related to this recall.
Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP are indicated to control high blood pressure and for the treatment of heart failure. Patients who prescribed Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP should continue taking their medication, as the risk of harm to the patient's health may be higher if the treatment is stopped immediately without any alternative treatment. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.
The products subject to recall are listed below and packaged in bottles. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products.
NDC Name and strength Count Lot number Expiry
65862-737-30 Amlodipine and Valsartan Tablets USP5mg/160mg 30 VESA17013-A 10/2019
65862-737-30 Amlodipine and Valsartan Tablets USP5mg/160mg 30 VESA17014-A 10/2019
65862-737-30 Amlodipine and Valsartan Tablets USP5mg/160mg 30 VESA18001-A 12/2019
65862-737-30 Amlodipine and Valsartan Tablets USP5mg/160mg 30 VESA18002-A 12/2019
65862-739-30 Amlodipine and Valsartan Tablets USP10mg/160mg 30 VFSA17008-A 10/2019
65862-739-30 Amlodipine and Valsartan Tablets USP10mg/160mg 30 VFSA17010-A 10/2019
65862-739-30 Amlodipine and Valsartan Tablets USP10mg/160mg 30 VFSA18002-A 01/2020
65862-739-30 Amlodipine and Valsartan Tablets USP10mg/160mg 30 VFSA18003-A 01/2020
65862-739-30 Amlodipine and Valsartan Tablets USP10mg/160mg 30 VFSA18007-A 03/2020
65862-739-30 Amlodipine and Valsartan Tablets USP10mg/160mg 30 VFSA18008-A 03/2020
65862-740-30 Amlodipine and Valsartan Tablets USP10mg /320mg 30 VKSA17008-A 05/2019
65862-740-30 Amlodipine and Valsartan Tablets USP10mg /320mg 30 VKSA17014-A 10/2019
65862-740-30 Amlodipine and Valsartan Tablets USP10mg /320mg 30 VKSA17015-A 10/2019
65862-740-30 Amlodipine and Valsartan Tablets USP10mg /320mg 30 VKSA17016-A 10/2019
65862-740-30 Amlodipine and Valsartan Tablets USP10mg /320mg 30 VKSA17017-A 10/2019
65862-740-30 Amlodipine and Valsartan Tablets USP10mg /320mg 30 VKSA18002-A 01/2020
65862-740-30 Amlodipine and Valsartan Tablets USP10mg /320mg 30 VKSA18004-A 01/2020
65862-738-30 Amlodipine and Valsartan Tablets USP5mg /320mg 30 VMSA17012-A 11/2019
65862-738-30 Amlodipine and Valsartan Tablets USP5mg /320mg 30 VMSA17013-A 11/2019
65862-738-30 Amlodipine and Valsartan Tablets USP5mg /320mg 30 VMSA17014-A 11/2019
65862-738-30 Amlodipine and Valsartan Tablets USP5mg /320mg 30 VMSA17015-A 11/2019
65862-738-30 Amlodipine and Valsartan Tablets USP5mg /320mg 30 VMSA17016-A 11/2019
65862-738-30 Amlodipine and Valsartan Tablets USP5mg /320mg 30 VMSA17017-A 11/2019
65862-739-30 Amlodipine and Valsartan Tablets USP10mg/160mg 30 VFSA17009-A 10/2019
65862-740-30 Amlodipine and Valsartan Tablets USP 10mg /320mg 30 VKSA18005-A 03/2020
65862-740-30 Amlodipine and Valsartan Tablets USP 10mg /320mg 30 VKSA18001-A 01/2020
65862-550-90 Valsartan and Hydrochlorothiazide tablets & USP 320mg/12.5mg 90 HRSA17033-A 10/2020
65862-550-90 Valsartan and Hydrochlorothiazide tablets & USP 320mg/12.5mg 90 HRSA17034-A 10/2020
65862-550-90 Valsartan and Hydrochlorothiazide tablets & USP 320mg/12.5mg 90 HRSA17035-A 10/2020
65862-550-90 Valsartan and Hydrochlorothiazide tablets & USP 320mg/12.5mg 90 HRSA17036-A 10/2020
65862-550-90 Valsartan and Hydrochlorothiazide tablets & USP 320mg/12.5mg 90 HRSA17037-A 10/2020
65862-548-90 Valsartan and Hydrochlorothiazide Tablets USP160mg/12.5mg 90 HTSA17033-A 10/2020
65862-548-90 Valsartan and Hydrochlorothiazide Tablets USP160mg/12.5mg 90 HTSA17034-A 10/2020
65862-548-90 Valsartan and Hydrochlorothiazide Tablets USP160mg/12.5mg 90 HTSA17035-A 10/2020
65862-548-90 Valsartan and Hydrochlorothiazide Tablets USP160mg/12.5mg 90 HTSA17036-A 10/2020
65862-548-90 Valsartan and Hydrochlorothiazide Tablets USP160mg/12.5mg 90 HTSA17040-A 10/2020
65862-548-90 Valsartan and Hydrochlorothiazide Tablets USP160mg/12.5mg 90 HTSA17041-A 11/2020
65862-548-90 Valsartan and Hydrochlorothiazide Tablets USP160mg/12.5mg 90 HTSA17042-A 11/2020
65862-548-90 Valsartan and Hydrochlorothiazide Tablets USP160mg/12.5mg 90 HTSA17043-A 11/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17049-A 08/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17054-A 10/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17055-A 10/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17056-A 10/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17057-A 10/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17058-A 10/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17059-A 10/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17060-A 10/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17062-A 10/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17066-A 10/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17067-A 11/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17068-A 11/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17069-A 11/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB18001-A 12/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB18002-A 12/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB18003-A 12/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB18004-A 12/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB18005-A 12/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB18006-A 12/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB18007-A 12/2020
65862-547-90 Valsartan and Hydrochlorothiazide tablets USP 80mg/12.5mg 90 HVSA17011-A 11/2020
65862-547-90 Valsartan and Hydrochlorothiazide tablets USP 80mg/12.5mg 90 HVSA17012-A 11/2020
65862-547-90 Valsartan and Hydrochlorothiazide tablets USP 80mg/12.5mg 90 HVSA18001-A 12/2020
65862-549-90 Valsartan and Hydrochlorothiazide tablets USP 160mg/25mg 90 HVSB17023-A 08/2020
65862-549-90 Valsartan and Hydrochlorothiazide tablets USP 160mg/25mg 90 HVSB17036-A 11/2020
65862-549-90 Valsartan and Hydrochlorothiazide tablets USP 160mg/25mg 90 HVSB17037-A 11/2020
65862-549-90 Valsartan and Hydrochlorothiazide tablets USP 160mg/25mg 90 HVSB17038-A 11/2020
65862-549-90 Valsartan and Hydrochlorothiazide tablets USP 160mg/25mg 90 HVSB17039-A 11/2020
65862-549-90 Valsartan and Hydrochlorothiazide tablets USP 160mg/25mg 90 HVSB17040-B 11/2020
65862-549-90 Valsartan and Hydrochlorothiazide tablets USP 160mg/25mg 90 HVSB18001-A 12/2020
65862-549-90 Valsartan and Hydrochlorothiazide tablets USP 160mg/25mg 90 HVSB18002-A 12/2020
65862-549-90 Valsartan and Hydrochlorothiazide tablets USP 160mg/25mg 90 HVSB18003-A 12/2020
65862-549-90 Valsartan and Hydrochlorothiazide tablets USP 160mg/25mg 90 HVSB18004-A 12/2020
65862-548-90 Valsartan and Hydrochlorothiazide Tablets USP 160mg/12.5mg 90 HTSA17037-A 10/2020
65862-548-90 Valsartan and Hydrochlorothiazide Tablets USP 160mg/12.5mg 90 HTSA17039-A 10/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17063-A 10/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17064-A 10/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17065-A 10/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP & 320/25mg 90 HTSB18029-A 03/2021
65862-573-90 Valsartan Tablets USP 320mg 90 VUSD17008-A 07/2019
65862-573-90 Valsartan Tablets USP 320mg 90 VUSD17009-A 09/2019
Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP were distributed nationwide to Aurobindo Pharma USA, Inc. wholesale, distributor, repackager and retail customers. Aurobindo Pharma USA, Inc. is notifying its distributors and customers by phone and in writing to immediately discontinue distribution of the specific lots being recalled and to notify their sub-accounts. Aurobindo Pharma USA, Inc. is arranging for return of all recalled products to Inmar/CLS Medturn. Instructions for returning recalled products are given in the recall letter.
Consumers with medical questions regarding this recall or to report an adverse event can contact Aurobindo Pharma USA, Inc. at:
1-866-850-2876 Option 2
pvg@aurobindousa.com
Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Any general questions regarding the return of this product please contact Inmar\CLS-Medturn at 1-877-208-2407 or email rxrecalls@inmar.com (live calls received 9 am -5:00 pm Eastern Time).
Contact
Consumers
Aurobindo Pharma USA
pvg@aurobindousa.com
1-866-850-2876 Option 2
Consumers
Inmar\CLS-Medturn
rxrecalls@inmar.com
1-877-208-2407
Aurobindo Pharma USA, Inc. Initiates Voluntary Nationwide Consumer Level Recall of 80 Lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP, Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity
For Immediate Release
December 31, 2018
Announcement
Aurobindo Pharma USA, Inc. is conducting a voluntary recall of 80 lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. The impurity detected in the finished drug product is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification. To date, Aurobindo Pharma USA, Inc. has not received any reports of adverse events related to this recall.
Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP are indicated to control high blood pressure and for the treatment of heart failure. Patients who prescribed Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP should continue taking their medication, as the risk of harm to the patient's health may be higher if the treatment is stopped immediately without any alternative treatment. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.
The products subject to recall are listed below and packaged in bottles. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products.
NDC Name and strength Count Lot number Expiry
65862-737-30 Amlodipine and Valsartan Tablets USP5mg/160mg 30 VESA17013-A 10/2019
65862-737-30 Amlodipine and Valsartan Tablets USP5mg/160mg 30 VESA17014-A 10/2019
65862-737-30 Amlodipine and Valsartan Tablets USP5mg/160mg 30 VESA18001-A 12/2019
65862-737-30 Amlodipine and Valsartan Tablets USP5mg/160mg 30 VESA18002-A 12/2019
65862-739-30 Amlodipine and Valsartan Tablets USP10mg/160mg 30 VFSA17008-A 10/2019
65862-739-30 Amlodipine and Valsartan Tablets USP10mg/160mg 30 VFSA17010-A 10/2019
65862-739-30 Amlodipine and Valsartan Tablets USP10mg/160mg 30 VFSA18002-A 01/2020
65862-739-30 Amlodipine and Valsartan Tablets USP10mg/160mg 30 VFSA18003-A 01/2020
65862-739-30 Amlodipine and Valsartan Tablets USP10mg/160mg 30 VFSA18007-A 03/2020
65862-739-30 Amlodipine and Valsartan Tablets USP10mg/160mg 30 VFSA18008-A 03/2020
65862-740-30 Amlodipine and Valsartan Tablets USP10mg /320mg 30 VKSA17008-A 05/2019
65862-740-30 Amlodipine and Valsartan Tablets USP10mg /320mg 30 VKSA17014-A 10/2019
65862-740-30 Amlodipine and Valsartan Tablets USP10mg /320mg 30 VKSA17015-A 10/2019
65862-740-30 Amlodipine and Valsartan Tablets USP10mg /320mg 30 VKSA17016-A 10/2019
65862-740-30 Amlodipine and Valsartan Tablets USP10mg /320mg 30 VKSA17017-A 10/2019
65862-740-30 Amlodipine and Valsartan Tablets USP10mg /320mg 30 VKSA18002-A 01/2020
65862-740-30 Amlodipine and Valsartan Tablets USP10mg /320mg 30 VKSA18004-A 01/2020
65862-738-30 Amlodipine and Valsartan Tablets USP5mg /320mg 30 VMSA17012-A 11/2019
65862-738-30 Amlodipine and Valsartan Tablets USP5mg /320mg 30 VMSA17013-A 11/2019
65862-738-30 Amlodipine and Valsartan Tablets USP5mg /320mg 30 VMSA17014-A 11/2019
65862-738-30 Amlodipine and Valsartan Tablets USP5mg /320mg 30 VMSA17015-A 11/2019
65862-738-30 Amlodipine and Valsartan Tablets USP5mg /320mg 30 VMSA17016-A 11/2019
65862-738-30 Amlodipine and Valsartan Tablets USP5mg /320mg 30 VMSA17017-A 11/2019
65862-739-30 Amlodipine and Valsartan Tablets USP10mg/160mg 30 VFSA17009-A 10/2019
65862-740-30 Amlodipine and Valsartan Tablets USP 10mg /320mg 30 VKSA18005-A 03/2020
65862-740-30 Amlodipine and Valsartan Tablets USP 10mg /320mg 30 VKSA18001-A 01/2020
65862-550-90 Valsartan and Hydrochlorothiazide tablets & USP 320mg/12.5mg 90 HRSA17033-A 10/2020
65862-550-90 Valsartan and Hydrochlorothiazide tablets & USP 320mg/12.5mg 90 HRSA17034-A 10/2020
65862-550-90 Valsartan and Hydrochlorothiazide tablets & USP 320mg/12.5mg 90 HRSA17035-A 10/2020
65862-550-90 Valsartan and Hydrochlorothiazide tablets & USP 320mg/12.5mg 90 HRSA17036-A 10/2020
65862-550-90 Valsartan and Hydrochlorothiazide tablets & USP 320mg/12.5mg 90 HRSA17037-A 10/2020
65862-548-90 Valsartan and Hydrochlorothiazide Tablets USP160mg/12.5mg 90 HTSA17033-A 10/2020
65862-548-90 Valsartan and Hydrochlorothiazide Tablets USP160mg/12.5mg 90 HTSA17034-A 10/2020
65862-548-90 Valsartan and Hydrochlorothiazide Tablets USP160mg/12.5mg 90 HTSA17035-A 10/2020
65862-548-90 Valsartan and Hydrochlorothiazide Tablets USP160mg/12.5mg 90 HTSA17036-A 10/2020
65862-548-90 Valsartan and Hydrochlorothiazide Tablets USP160mg/12.5mg 90 HTSA17040-A 10/2020
65862-548-90 Valsartan and Hydrochlorothiazide Tablets USP160mg/12.5mg 90 HTSA17041-A 11/2020
65862-548-90 Valsartan and Hydrochlorothiazide Tablets USP160mg/12.5mg 90 HTSA17042-A 11/2020
65862-548-90 Valsartan and Hydrochlorothiazide Tablets USP160mg/12.5mg 90 HTSA17043-A 11/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17049-A 08/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17054-A 10/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17055-A 10/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17056-A 10/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17057-A 10/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17058-A 10/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17059-A 10/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17060-A 10/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17062-A 10/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17066-A 10/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17067-A 11/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17068-A 11/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17069-A 11/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB18001-A 12/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB18002-A 12/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB18003-A 12/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB18004-A 12/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB18005-A 12/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB18006-A 12/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB18007-A 12/2020
65862-547-90 Valsartan and Hydrochlorothiazide tablets USP 80mg/12.5mg 90 HVSA17011-A 11/2020
65862-547-90 Valsartan and Hydrochlorothiazide tablets USP 80mg/12.5mg 90 HVSA17012-A 11/2020
65862-547-90 Valsartan and Hydrochlorothiazide tablets USP 80mg/12.5mg 90 HVSA18001-A 12/2020
65862-549-90 Valsartan and Hydrochlorothiazide tablets USP 160mg/25mg 90 HVSB17023-A 08/2020
65862-549-90 Valsartan and Hydrochlorothiazide tablets USP 160mg/25mg 90 HVSB17036-A 11/2020
65862-549-90 Valsartan and Hydrochlorothiazide tablets USP 160mg/25mg 90 HVSB17037-A 11/2020
65862-549-90 Valsartan and Hydrochlorothiazide tablets USP 160mg/25mg 90 HVSB17038-A 11/2020
65862-549-90 Valsartan and Hydrochlorothiazide tablets USP 160mg/25mg 90 HVSB17039-A 11/2020
65862-549-90 Valsartan and Hydrochlorothiazide tablets USP 160mg/25mg 90 HVSB17040-B 11/2020
65862-549-90 Valsartan and Hydrochlorothiazide tablets USP 160mg/25mg 90 HVSB18001-A 12/2020
65862-549-90 Valsartan and Hydrochlorothiazide tablets USP 160mg/25mg 90 HVSB18002-A 12/2020
65862-549-90 Valsartan and Hydrochlorothiazide tablets USP 160mg/25mg 90 HVSB18003-A 12/2020
65862-549-90 Valsartan and Hydrochlorothiazide tablets USP 160mg/25mg 90 HVSB18004-A 12/2020
65862-548-90 Valsartan and Hydrochlorothiazide Tablets USP 160mg/12.5mg 90 HTSA17037-A 10/2020
65862-548-90 Valsartan and Hydrochlorothiazide Tablets USP 160mg/12.5mg 90 HTSA17039-A 10/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17063-A 10/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17064-A 10/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg 90 HTSB17065-A 10/2020
65862-551-90 Valsartan and Hydrochlorothiazide Tablets USP & 320/25mg 90 HTSB18029-A 03/2021
65862-573-90 Valsartan Tablets USP 320mg 90 VUSD17008-A 07/2019
65862-573-90 Valsartan Tablets USP 320mg 90 VUSD17009-A 09/2019
Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP were distributed nationwide to Aurobindo Pharma USA, Inc. wholesale, distributor, repackager and retail customers. Aurobindo Pharma USA, Inc. is notifying its distributors and customers by phone and in writing to immediately discontinue distribution of the specific lots being recalled and to notify their sub-accounts. Aurobindo Pharma USA, Inc. is arranging for return of all recalled products to Inmar/CLS Medturn. Instructions for returning recalled products are given in the recall letter.
Consumers with medical questions regarding this recall or to report an adverse event can contact Aurobindo Pharma USA, Inc. at:
1-866-850-2876 Option 2
pvg@aurobindousa.com
Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Any general questions regarding the return of this product please contact Inmar\CLS-Medturn at 1-877-208-2407 or email rxrecalls@inmar.com (live calls received 9 am -5:00 pm Eastern Time).
Contact
Consumers
Aurobindo Pharma USA
pvg@aurobindousa.com
1-866-850-2876 Option 2
Consumers
Inmar\CLS-Medturn
rxrecalls@inmar.com
1-877-208-2407
Thursday, December 27, 2018
Ford Recalling 874,000 Pickup Trucks in North America for Fire Risks
WASHINGTON (Reuters) - Ford Motor Co said Friday it is recalling 874,000 pickup trucks in North America with engine block heaters for fire risks.
The second largest U.S. automaker said the recall covers some 2015-2019 Ford F-150 trucks, along with the 2017-2019 Ford F-250 Super Duty, F-350 Super Duty, F-450 Super Duty, and F-550 Super Duty pick-up trucks.
Ford said water and contaminants may get into the block heater cable's splice connector, causing corrosion and damage and potentially a fire. Ford told U.S. regulators it is aware of reports of three fires in Canada linked to the issue, but unaware of any reports of accidents or injuries.
The recall covers 410,000 vehicles in the United States and about 464,000 in Canada. Ford dealers will inspect and seal the block heater cable, or replace it if necessary. The recall will begin early next month.
(Reporting by David Shepardson; Editing by Chizu Nomiyama and Nick Zieminski)
The second largest U.S. automaker said the recall covers some 2015-2019 Ford F-150 trucks, along with the 2017-2019 Ford F-250 Super Duty, F-350 Super Duty, F-450 Super Duty, and F-550 Super Duty pick-up trucks.
Ford said water and contaminants may get into the block heater cable's splice connector, causing corrosion and damage and potentially a fire. Ford told U.S. regulators it is aware of reports of three fires in Canada linked to the issue, but unaware of any reports of accidents or injuries.
The recall covers 410,000 vehicles in the United States and about 464,000 in Canada. Ford dealers will inspect and seal the block heater cable, or replace it if necessary. The recall will begin early next month.
(Reporting by David Shepardson; Editing by Chizu Nomiyama and Nick Zieminski)
Monday, November 26, 2018
Nationwide Recall of Pharmaceuticals
Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient
For Immediate Release
November 20, 2018
Contact
Consumers
888-406-9305
Announcement
Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall to the consumer level of select lots of Valsartan-containing products, including six lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, and 10mg/320mg strengths), seven lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg, and 320 mg strengths), and two lots of Valsartan and Hydrochlorothiazide Tablets, USP 320mg/25mg strength. These products are being recalled due to detected trace amounts of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Valsartan, USP, manufactured by Mylan Laboratories Limited. NDEA is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen according to the International Agency for Research on Cancer (IARC).
The finished products are manufactured by Mylan Pharmaceuticals Inc. and Mylan Laboratories Limited. These batches were distributed in the U.S. between March 2017 and November 2018. The recalled batches are as follows:
NDC Product Description Strength Size Lot Number Expiry
0378-1721-93 Amlodipine and Valsartan Tablets, USP 5mg/160mg Bottles of 30 3066051 3/2019
0378-1722-93 Amlodipine and Valsartan Tablets, USP 10mg/160mg Bottles of 30 3079500 1/2020
0378-1724-93 Amlodipine and Valsartan Tablets, USP 10mg/320mg Bottles of 30 3061986 11/2018
0378-1724-93 Amlodipine and Valsartan Tablets, USP 10mg/320mg Bottles of 30 3079709 1/2020
0378-1724-93 Amlodipine and Valsartan Tablets, USP 10mg/320mg Bottles of 30 3077618 11/2019
0378-1724-93 Amlodipine and Valsartan Tablets, USP 10mg/320mg Bottles of 30 3079708 1/2020
0378-5813-77 Valsartan Tablets, USP 80mg Bottles of 90 3063782 1/2019
0378-5814-77 Valsartan Tablets, USP 160mg Bottles of 90 3071352 7/2019
0378-5807-93 Valsartan Tablets, USP 40mg Bottles of 30 3061169 11/2018
0378-5815-77 Valsartan Tablets, USP 320mg Bottles of 90 3081499 3/2020
0378-5815-77 Valsartan Tablets, USP 320mg Bottles of 90 3080009 2/2020
0378-5815-77 Valsartan Tablets, USP 320mg Bottles of 90 3080010 2/2020
0378-5815-77 Valsartan Tablets, USP 320mg Bottles of 90 3079205 1/2020
0378-6325-05 Valsartan and Hydrochlorothiazide Tablets, USP 320mg/25mg Bottles of 500 3084886 2/2019
0378-6325-05 Valsartan and Hydrochlorothiazide Tablets, USP 320mg/25mg Bottles of 500 3093804 12/2019
Valsartan is used for the treatment of high blood pressure for the treatment of heart failure, and to reduce cardiovascular mortality following myocardial infarction. Valsartan in combination with amlodipine or hydrochlorothiazide is used for the treatment of high blood pressure. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication. Patients who are on valsartan should continue taking their medication, as the risk of harm to the patient's health may be higher if the treatment is stopped immediately without any alternative treatment.
Mylan is notifying its distributors and customers by letter and is arranging for return of all recalled products. Wholesalers, retailers and consumers that are in possession of recalled product should contact Stericycle at 1-888-406-9305 for the return of the recalled product. Normal business hours are Monday through Friday 8 a.m. to 5 p.m. EST.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these drug products.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report Online: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
About Mylan
Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We offer a growing portfolio of more than 7,500 marketed products around the world, including antiretroviral therapies on which more than 40% of people being treated for HIV/AIDS globally depend. We market our products in more than 165 countries and territories. We are one of the world's largest producers of active pharmaceutical ingredients. Every member of our approximately 35,000-strong workforce is dedicated to creating better health for a better world, one person at a time. Learn more at Mylan.com.
For Immediate Release
November 20, 2018
Contact
Consumers
888-406-9305
Announcement
Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall to the consumer level of select lots of Valsartan-containing products, including six lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, and 10mg/320mg strengths), seven lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg, and 320 mg strengths), and two lots of Valsartan and Hydrochlorothiazide Tablets, USP 320mg/25mg strength. These products are being recalled due to detected trace amounts of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Valsartan, USP, manufactured by Mylan Laboratories Limited. NDEA is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen according to the International Agency for Research on Cancer (IARC).
The finished products are manufactured by Mylan Pharmaceuticals Inc. and Mylan Laboratories Limited. These batches were distributed in the U.S. between March 2017 and November 2018. The recalled batches are as follows:
NDC Product Description Strength Size Lot Number Expiry
0378-1721-93 Amlodipine and Valsartan Tablets, USP 5mg/160mg Bottles of 30 3066051 3/2019
0378-1722-93 Amlodipine and Valsartan Tablets, USP 10mg/160mg Bottles of 30 3079500 1/2020
0378-1724-93 Amlodipine and Valsartan Tablets, USP 10mg/320mg Bottles of 30 3061986 11/2018
0378-1724-93 Amlodipine and Valsartan Tablets, USP 10mg/320mg Bottles of 30 3079709 1/2020
0378-1724-93 Amlodipine and Valsartan Tablets, USP 10mg/320mg Bottles of 30 3077618 11/2019
0378-1724-93 Amlodipine and Valsartan Tablets, USP 10mg/320mg Bottles of 30 3079708 1/2020
0378-5813-77 Valsartan Tablets, USP 80mg Bottles of 90 3063782 1/2019
0378-5814-77 Valsartan Tablets, USP 160mg Bottles of 90 3071352 7/2019
0378-5807-93 Valsartan Tablets, USP 40mg Bottles of 30 3061169 11/2018
0378-5815-77 Valsartan Tablets, USP 320mg Bottles of 90 3081499 3/2020
0378-5815-77 Valsartan Tablets, USP 320mg Bottles of 90 3080009 2/2020
0378-5815-77 Valsartan Tablets, USP 320mg Bottles of 90 3080010 2/2020
0378-5815-77 Valsartan Tablets, USP 320mg Bottles of 90 3079205 1/2020
0378-6325-05 Valsartan and Hydrochlorothiazide Tablets, USP 320mg/25mg Bottles of 500 3084886 2/2019
0378-6325-05 Valsartan and Hydrochlorothiazide Tablets, USP 320mg/25mg Bottles of 500 3093804 12/2019
Valsartan is used for the treatment of high blood pressure for the treatment of heart failure, and to reduce cardiovascular mortality following myocardial infarction. Valsartan in combination with amlodipine or hydrochlorothiazide is used for the treatment of high blood pressure. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication. Patients who are on valsartan should continue taking their medication, as the risk of harm to the patient's health may be higher if the treatment is stopped immediately without any alternative treatment.
Mylan is notifying its distributors and customers by letter and is arranging for return of all recalled products. Wholesalers, retailers and consumers that are in possession of recalled product should contact Stericycle at 1-888-406-9305 for the return of the recalled product. Normal business hours are Monday through Friday 8 a.m. to 5 p.m. EST.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these drug products.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report Online: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
About Mylan
Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We offer a growing portfolio of more than 7,500 marketed products around the world, including antiretroviral therapies on which more than 40% of people being treated for HIV/AIDS globally depend. We market our products in more than 165 countries and territories. We are one of the world's largest producers of active pharmaceutical ingredients. Every member of our approximately 35,000-strong workforce is dedicated to creating better health for a better world, one person at a time. Learn more at Mylan.com.
Monday, November 12, 2018
Duncan Hines Recalls Cake Mixes Due to Potential Presence of Salmonella
Duncan Hines Classic White, Classic Butter Golden, Signature Confetti and Classic Yellow Cake Mixes Recalled Due to Potential Presence of Salmonella
For Immediate Release
November 5, 2018
Contact
Consumers
Consumer Care team
1-888-299-7646
Announcement
CHICAGO - Conagra Brands is collaborating with health officials in connection with a positive finding of Salmonella in a retail sample of Duncan Hines Classic White cake mix that may be linked to a Salmonella outbreak that is currently being investigated by CDC and FDA. While it has not been definitively concluded that this product is linked to the outbreak and the investigation is still ongoing, Conagra has decided to voluntarily recall the specific Duncan Hines variety identified (Classic White) and three other varieties (Classic Butter Golden, Signature Confetti and Classic Yellow) made during the same time period out of an abundance of caution.
Five occurrences of illnesses due to Salmonella are being researched by CDC and FDA as part of this investigation. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.
Several of the individuals reported consuming a cake mix at some point prior to becoming ill, and some may have also consumed these products raw and not baked. Consumers are reminded not to consume any raw batter. Cake mixes and batter can be made with ingredients such as eggs or flour which can carry risks of bacteria that are rendered harmless by baking, frying or boiling. Consumers are reminded to wash their hands, work surfaces, and utensils thoroughly after contact with raw batter products, to follow baking instructions, and to never eat raw batter.
The products covered by this recall were distributed for retail sale in the U.S. and limited international exports; the specific product information is listed below. No other Duncan Hines products or Conagra Brands' products are impacted by this recall.
Product Description & Brand Product UPC Best If Used By Date
(located on top of box)
Duncan Hines Classic White Cake 15.25oz. 644209307500 MAR 7 2019
MAR 8 2019
MAR 9 2019
MAR 10 2019
MAR 12 2019
MAR 13 2019
Duncan Hines Classic Yellow Cake 15.25oz. 644209307494 MAR 9 2019
MAR 10 2019
MAR 12 2019
MAR 13 2019
Duncan Hines Classic Butter Golden Cake 15.25oz. 644209307593 MAR 7 2019
MAR 8 2019
MAR 9 2019
Duncan Hines Signature Confetti Cake 15.25oz. 644209414550 MAR 12 2019
MAR 13 2019
Consumers who have purchased these items are advised not to consume them and to return them to the store where originally purchased. Conagra Brands is cooperating with the FDA on this recall and is working with customers to ensure the packages are removed from store shelves and are no longer distributed. Consumers with questions should call our Consumer Care team at 1-888-299-7646, open 9 am through 5 pm EST, Monday through Friday or visit www.duncanhines.com.
For Immediate Release
November 5, 2018
Contact
Consumers
Consumer Care team
1-888-299-7646
Announcement
CHICAGO - Conagra Brands is collaborating with health officials in connection with a positive finding of Salmonella in a retail sample of Duncan Hines Classic White cake mix that may be linked to a Salmonella outbreak that is currently being investigated by CDC and FDA. While it has not been definitively concluded that this product is linked to the outbreak and the investigation is still ongoing, Conagra has decided to voluntarily recall the specific Duncan Hines variety identified (Classic White) and three other varieties (Classic Butter Golden, Signature Confetti and Classic Yellow) made during the same time period out of an abundance of caution.
Five occurrences of illnesses due to Salmonella are being researched by CDC and FDA as part of this investigation. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.
Several of the individuals reported consuming a cake mix at some point prior to becoming ill, and some may have also consumed these products raw and not baked. Consumers are reminded not to consume any raw batter. Cake mixes and batter can be made with ingredients such as eggs or flour which can carry risks of bacteria that are rendered harmless by baking, frying or boiling. Consumers are reminded to wash their hands, work surfaces, and utensils thoroughly after contact with raw batter products, to follow baking instructions, and to never eat raw batter.
The products covered by this recall were distributed for retail sale in the U.S. and limited international exports; the specific product information is listed below. No other Duncan Hines products or Conagra Brands' products are impacted by this recall.
Product Description & Brand Product UPC Best If Used By Date
(located on top of box)
Duncan Hines Classic White Cake 15.25oz. 644209307500 MAR 7 2019
MAR 8 2019
MAR 9 2019
MAR 10 2019
MAR 12 2019
MAR 13 2019
Duncan Hines Classic Yellow Cake 15.25oz. 644209307494 MAR 9 2019
MAR 10 2019
MAR 12 2019
MAR 13 2019
Duncan Hines Classic Butter Golden Cake 15.25oz. 644209307593 MAR 7 2019
MAR 8 2019
MAR 9 2019
Duncan Hines Signature Confetti Cake 15.25oz. 644209414550 MAR 12 2019
MAR 13 2019
Consumers who have purchased these items are advised not to consume them and to return them to the store where originally purchased. Conagra Brands is cooperating with the FDA on this recall and is working with customers to ensure the packages are removed from store shelves and are no longer distributed. Consumers with questions should call our Consumer Care team at 1-888-299-7646, open 9 am through 5 pm EST, Monday through Friday or visit www.duncanhines.com.
Thursday, October 25, 2018
Check Your Freezers - Chicken and Beef Products Recalls
Chicken and Beef Products Recalled Due to Possible Salmonella and Listeria Monocytogenes Contamination
(Our product safety information is produced by our editors and some content sourced from information provided by the respective company directly and government regulatory agencies. If this is a recall we encourage you to contact the company directly for complete information.)
Envolve Foods Recalls Chicken and Beef Products due to Possible Salmonella and Listeria Monocytogenes Contamination in Vegetables
Class I Recall 100-2018
Health Risk: High
Oct 19, 2018
Congressional and Public Affairs
Autumn Canaday
(202) 720-9113
Press@fsis.usda.gov
WASHINGTON, Oct. 19, 2018 - Envolve Foods, a Corona, Calif. establishment, is recalling approximately 292,764 pounds of ready-to-eat chicken and beef products that contain a vegetable ingredient that may be contaminated with Salmonella and Listeria monocytogenes, the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced today.
The ready-to-eat chicken and beef items were produced and packaged from Feb. 2, 2017 through Oct. 12, 2018. The following products are subject to recall:
? 22-oz. plastic bags containing "simple truth, Chicken Bibimbap" and a case code number of 011110890108 on the label and use by/sell by dates of 11/2/18 through 3/12/20.
? 22-oz. plastic bags containing "simple truth, Thai Style Green Curry" and a case code number of 011110816382 on the label and use by/sell by dates of 3/13/19 through 1/24/20.
? 22-oz. plastic bags containing "simple truth, Chicken Tikka Masala" and a case code of 011110890092 on the label and use by/sell by dates of 3/22/19 through 4/12/19.
? 10-lb. cases containing "CADENCE GOURMET, Steak Fajitas," with an item number of SS00024, and an expiration dates of 11/1/2018 through 01/18/19, on the label.
? 10-lb. cases containing "CADENCE GOURMET, Tuscan Tomato Basil Chicken & Sausage," with an item number of SS00032, and an expiration dates of 10/20/18 through 01/09/19 on the label.
? 10-lb. cases containing "CADENCE GOURMET, Rustic Toasted Tomato Basil Chicken & Vegetables," with an item number of SS00047, and an expiration dates of 2/05/19 through 10/12/19 on the label.
The products subject to recall bear establishment number "EST. 44857" inside the USDA mark of inspection. These items were shipped to distribution warehouses nationwide.
The problem was discovered on October 16, 2018 when Envolve Foods received notification that the vegetables used in the production of their ready-to-eat products were being recalled by their vegetable supplier due to Salmonella and Listeria monocytogenes concerns.
There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.
Consumption of food contaminated with Salmonella can cause salmonellosis, one of the most common bacterial foodborne illnesses. The most common symptoms of salmonellosis are diarrhea, abdominal cramps, and fever within 12 to 72 hours after eating the contaminated product. The illness usually lasts 4 to 7 days. Most people recover without treatment. In some persons, however, the diarrhea may be so severe that the patient needs to be hospitalized.
Consumption of food contaminated with L. monocytogenes can cause listeriosis, a serious infection that primarily affects older adults, persons with weakened immune systems, and pregnant women and their newborns. Less commonly, persons outside these risk groups are affected.
Listeriosis can cause fever, muscle aches, headache, stiff neck, confusion, loss of balance and convulsions sometimes preceded by diarrhea or other gastrointestinal symptoms. An invasive infection spreads beyond the gastrointestinal tract. In pregnant women, the infection can cause miscarriages, stillbirths, premature delivery or life-threatening infection of the newborn. In addition, serious and sometimes fatal infections in older adults and persons with weakened immune systems. Listeriosis is treated with antibiotics. Persons in the higher-risk categories who experience flu-like symptoms within two months after eating contaminated food should seek medical care and tell the health care provider about eating the contaminated food.
FSIS is concerned that some product may be frozen and in consumers' freezers. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.
(Our product safety information is produced by our editors and some content sourced from information provided by the respective company directly and government regulatory agencies. If this is a recall we encourage you to contact the company directly for complete information.)
Envolve Foods Recalls Chicken and Beef Products due to Possible Salmonella and Listeria Monocytogenes Contamination in Vegetables
Class I Recall 100-2018
Health Risk: High
Oct 19, 2018
Congressional and Public Affairs
Autumn Canaday
(202) 720-9113
Press@fsis.usda.gov
WASHINGTON, Oct. 19, 2018 - Envolve Foods, a Corona, Calif. establishment, is recalling approximately 292,764 pounds of ready-to-eat chicken and beef products that contain a vegetable ingredient that may be contaminated with Salmonella and Listeria monocytogenes, the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced today.
The ready-to-eat chicken and beef items were produced and packaged from Feb. 2, 2017 through Oct. 12, 2018. The following products are subject to recall:
? 22-oz. plastic bags containing "simple truth, Chicken Bibimbap" and a case code number of 011110890108 on the label and use by/sell by dates of 11/2/18 through 3/12/20.
? 22-oz. plastic bags containing "simple truth, Thai Style Green Curry" and a case code number of 011110816382 on the label and use by/sell by dates of 3/13/19 through 1/24/20.
? 22-oz. plastic bags containing "simple truth, Chicken Tikka Masala" and a case code of 011110890092 on the label and use by/sell by dates of 3/22/19 through 4/12/19.
? 10-lb. cases containing "CADENCE GOURMET, Steak Fajitas," with an item number of SS00024, and an expiration dates of 11/1/2018 through 01/18/19, on the label.
? 10-lb. cases containing "CADENCE GOURMET, Tuscan Tomato Basil Chicken & Sausage," with an item number of SS00032, and an expiration dates of 10/20/18 through 01/09/19 on the label.
? 10-lb. cases containing "CADENCE GOURMET, Rustic Toasted Tomato Basil Chicken & Vegetables," with an item number of SS00047, and an expiration dates of 2/05/19 through 10/12/19 on the label.
The products subject to recall bear establishment number "EST. 44857" inside the USDA mark of inspection. These items were shipped to distribution warehouses nationwide.
The problem was discovered on October 16, 2018 when Envolve Foods received notification that the vegetables used in the production of their ready-to-eat products were being recalled by their vegetable supplier due to Salmonella and Listeria monocytogenes concerns.
There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.
Consumption of food contaminated with Salmonella can cause salmonellosis, one of the most common bacterial foodborne illnesses. The most common symptoms of salmonellosis are diarrhea, abdominal cramps, and fever within 12 to 72 hours after eating the contaminated product. The illness usually lasts 4 to 7 days. Most people recover without treatment. In some persons, however, the diarrhea may be so severe that the patient needs to be hospitalized.
Consumption of food contaminated with L. monocytogenes can cause listeriosis, a serious infection that primarily affects older adults, persons with weakened immune systems, and pregnant women and their newborns. Less commonly, persons outside these risk groups are affected.
Listeriosis can cause fever, muscle aches, headache, stiff neck, confusion, loss of balance and convulsions sometimes preceded by diarrhea or other gastrointestinal symptoms. An invasive infection spreads beyond the gastrointestinal tract. In pregnant women, the infection can cause miscarriages, stillbirths, premature delivery or life-threatening infection of the newborn. In addition, serious and sometimes fatal infections in older adults and persons with weakened immune systems. Listeriosis is treated with antibiotics. Persons in the higher-risk categories who experience flu-like symptoms within two months after eating contaminated food should seek medical care and tell the health care provider about eating the contaminated food.
FSIS is concerned that some product may be frozen and in consumers' freezers. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.
Wednesday, April 23, 2008
April Recalls:
Fire Hazard Recalls:
Gas Water Heater by A.O. Smith due to Fire and Carbon Monoxide Hazards; A.O. Smith of Ashland City, Tenn. is recalling Natural and Propane Gas Water Heaters. The flue's gas temperature can exceed safe limits. Thus posing a fire hazard by exceeding safe temperatures in the venting unit. Also, the unit's exhaust possibly can leak which creates a carbon monoxide danger.
Serenity Spa Hot Tubs; Gecko Alliance of Quebec, Canada is recalling the spas due to the controls can possibly overheat thus causing a fire hazard.
Helicopter Battery Chargers; Hobby-Lobby International of Brentwood, Tenn. is recalling Lithium-polymer battery chargers and Lithium-polymer batteries due to they can cause a fire hazard by igniting while charging.
Charge-It-All Valets; HSN of St. Petersburg, FL. is recalling all charge-it-all-valets due to the wiring in the powerstrip is the wrong size. Thus causing a fire hazard.
Deck Cleaner; Cabot Stains of Newburypoint, Mass. is recalling Cabot Composite Deck Cleaner due to the fact that it reacts with the packaging by releasing a chlorine gas and heat. Thus it creates a fire and inhalation hazard.
Candle Holders; Walmart of Bentonville, Ark. is recalling Holiday Times Candleholders due to glass holder can break causing cuts, and they can easily tip over causing fires.
Heating and Cooling Units; Goodman Manufacturing of Houstan, Tex. is recalling Gas-Electric Heating & Cooling Units due to the wrong wiring could be installed thus a possibility of a fire could result.
Fire Alarm Control Panel; Gamewell-FCI of Northford, Conn. is recalling Gamewell-FCI 7100 Series Fire Alarm Control Panels due to main circuit board malfunction. Thus when there is a malfunction there is no alert sound to signify it.
Strangulation/Choking Hazard Recalls:
Children's Hooded Sweatshirts; Brents-Riordan of Shreveport, La. is recalling hooded jackets and sweatshirts due to the drawstring through the hood cause a strangulation hazard.
Imaginarium Activity Centers; Toys r Us of Wayne, NJ is recalling Imaginarium multi-sided activity centers and jungle activity centers because the small parts on the toys can come off and children can choke on them.
Plush Insect Toys; Dollar Tree Stores of Chesapeake, Va. is recalling Cuddly Cousins Plush Insect Toys due to their small parts can cause a choking hazard to small children.
Children's Board Book Sets; Dalmation Press of Franklin, Tenn. is recalling Little Builder children's board book sets with toys due to they can cause a choking hazard. The hazard is created because the tailgate of the toy dump truck and the cylinder of the toy concrete mixer can come off.
Magnetic Dart Boards; Henry Gordy of Plainfield, N.J. is recalling Fun 'n Games magnetic dart boards due to the magnets at the end of the darts can come off. If a small child ingests these magnets they can choke, have other problems and sometimes even die.
Lead Paint Recalls:
Lock and Leash Locks; Master Lock of Oak Creek, Wis. is recalling the Lock and Leash Locks due to lead in the red paint exceeds regulations.
Western Rider Push Toys; Santa's Toy Corp. of Los Angeles, Calif. is recalling Western Rider Push Toys due to lead in paint on glove, pants and shirt of rider exceeds regulations.
Seasonal Writing Pens; Michaels Stores of Irving, Texas is recalling all seasonal writing pens= Easter, Flowered, Christmas and Spooky due to their coating exceeds the regulations for lead.
Fake Teeth; FUNTASTIC of Houstan, Texas is recalling Hillbilly teeth due to the gray paint exceeds regulations.
Children's Sunglasses; StyleMark of Osmond Beach, Fla. is recalling Children's Main Street Drag Sunglasses due to orange lettering on temples, of glasses exceeds regulations.
Toy Robots; OKK Trading of Commerce, Calif. is recalling Interchange toy robots due to lead in surface paint exceeds regulations.
cpsc
Gas Water Heater by A.O. Smith due to Fire and Carbon Monoxide Hazards; A.O. Smith of Ashland City, Tenn. is recalling Natural and Propane Gas Water Heaters. The flue's gas temperature can exceed safe limits. Thus posing a fire hazard by exceeding safe temperatures in the venting unit. Also, the unit's exhaust possibly can leak which creates a carbon monoxide danger.
Serenity Spa Hot Tubs; Gecko Alliance of Quebec, Canada is recalling the spas due to the controls can possibly overheat thus causing a fire hazard.
Helicopter Battery Chargers; Hobby-Lobby International of Brentwood, Tenn. is recalling Lithium-polymer battery chargers and Lithium-polymer batteries due to they can cause a fire hazard by igniting while charging.
Charge-It-All Valets; HSN of St. Petersburg, FL. is recalling all charge-it-all-valets due to the wiring in the powerstrip is the wrong size. Thus causing a fire hazard.
Deck Cleaner; Cabot Stains of Newburypoint, Mass. is recalling Cabot Composite Deck Cleaner due to the fact that it reacts with the packaging by releasing a chlorine gas and heat. Thus it creates a fire and inhalation hazard.
Candle Holders; Walmart of Bentonville, Ark. is recalling Holiday Times Candleholders due to glass holder can break causing cuts, and they can easily tip over causing fires.
Heating and Cooling Units; Goodman Manufacturing of Houstan, Tex. is recalling Gas-Electric Heating & Cooling Units due to the wrong wiring could be installed thus a possibility of a fire could result.
Fire Alarm Control Panel; Gamewell-FCI of Northford, Conn. is recalling Gamewell-FCI 7100 Series Fire Alarm Control Panels due to main circuit board malfunction. Thus when there is a malfunction there is no alert sound to signify it.
Strangulation/Choking Hazard Recalls:
Children's Hooded Sweatshirts; Brents-Riordan of Shreveport, La. is recalling hooded jackets and sweatshirts due to the drawstring through the hood cause a strangulation hazard.
Imaginarium Activity Centers; Toys r Us of Wayne, NJ is recalling Imaginarium multi-sided activity centers and jungle activity centers because the small parts on the toys can come off and children can choke on them.
Plush Insect Toys; Dollar Tree Stores of Chesapeake, Va. is recalling Cuddly Cousins Plush Insect Toys due to their small parts can cause a choking hazard to small children.
Children's Board Book Sets; Dalmation Press of Franklin, Tenn. is recalling Little Builder children's board book sets with toys due to they can cause a choking hazard. The hazard is created because the tailgate of the toy dump truck and the cylinder of the toy concrete mixer can come off.
Magnetic Dart Boards; Henry Gordy of Plainfield, N.J. is recalling Fun 'n Games magnetic dart boards due to the magnets at the end of the darts can come off. If a small child ingests these magnets they can choke, have other problems and sometimes even die.
Lead Paint Recalls:
Lock and Leash Locks; Master Lock of Oak Creek, Wis. is recalling the Lock and Leash Locks due to lead in the red paint exceeds regulations.
Western Rider Push Toys; Santa's Toy Corp. of Los Angeles, Calif. is recalling Western Rider Push Toys due to lead in paint on glove, pants and shirt of rider exceeds regulations.
Seasonal Writing Pens; Michaels Stores of Irving, Texas is recalling all seasonal writing pens= Easter, Flowered, Christmas and Spooky due to their coating exceeds the regulations for lead.
Fake Teeth; FUNTASTIC of Houstan, Texas is recalling Hillbilly teeth due to the gray paint exceeds regulations.
Children's Sunglasses; StyleMark of Osmond Beach, Fla. is recalling Children's Main Street Drag Sunglasses due to orange lettering on temples, of glasses exceeds regulations.
Toy Robots; OKK Trading of Commerce, Calif. is recalling Interchange toy robots due to lead in surface paint exceeds regulations.
cpsc
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