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
Showing posts with label Valsartan. Show all posts
Showing posts with label Valsartan. Show all posts
Tuesday, January 1, 2019
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.
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