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.
Showing posts with label HIV. Show all posts
Showing posts with label HIV. Show all posts
Monday, November 26, 2018
Monday, April 7, 2008
Update For Clinics Spreading Disease:
The Nevada clinics will be held responsible to those they have put in harm's way. If you were treated at the clinics, I previously mentioned in my other articles, please get checked. Especially if it was between March 2004 and January 11, 2008.
The contamination was mainly due to syringes being contaminated by a patients blood borne disease. These would have then been injected into the vials that they were obviously re-using. Which were suppose to be single patient use only vials. Then the medication would be withdrawn once more from that vial and used on a new patient. Thus putting that patient at risk of a variety of diseases:HIV, Hepatitis B, and Hepatitis C. Symptoms of any of these diseases may not show up for years. Therefore, even if it was in 2004 that you used the clinic's services it is very important that you still get checked.
Symptoms for HIV are:
Flu like symptoms for the first 3-6 wks;
Between 2-10 yrs later you will develop any of the following number of symptoms;
Lack of energy
Weight loss
Frequent fevers and sweats
A thick, whitish coating of the tongue or mouth (thrush) that is caused by a yeast infection and sometimes accompanied by a sore throat
Severe or recurring vaginal yeast infections
Chronic pelvic inflammatory disease or severe and frequent infections like herpes zoster
Periods of extreme and unexplained fatigue that may be combined with headaches, lightheadedness, and/or dizziness
Rapid loss of more than 10 pounds of weight that is not due to increased physical exercise or dieting
Bruising more easily than normal
Long-lasting bouts of diarrhoea
Swelling or hardening of glands located in the throat, armpit, or groin
Periods of continued, deep, dry coughing
Increasing shortness of breath
The appearance of discoloured or purplish growths on the skin or inside the mouth
Unexplained bleeding from growths on the skin, from mucous membranes, or from any opening in the body
Recurring or unusual skin rashes
Severe numbness or pain in the hands or feet, the loss of muscle control and reflex, paralysis or loss of muscular strength
An altered state of consciousness, personality change, or mental deterioration
Children may grow slowly or fall sick frequently. HIV positive persons are also found to be more vulnerable to some cancers.
Symptoms for Hepatitis B:
One half of people infected will symptom free;
Others will have flu-like symptoms within 1-6 months with any of the following symptoms;
Appetite loss
Feeling tired (fatigue)
Nausea and vomiting
Itching all over the body
Pain over the liver (on the right side of the abdomen, under the lower rib cage)
Jaundice - A condition in which the skin and the whites of the eyes turn yellow in color
Urine becomes dark in color (like cola or tea).
Stools are pale in color (grayish or clay colored).
Many types of acute viral hepatitis have similar symptoms (hepatitis A, hepatitis C).
Fulminant hepatitis is an unusual illness. It is a severe form of acute hepatitis that can be life threatening if not treated right away. The symptoms develop very suddenly.
Mental disturbances such as confusion, lethargy, extreme sleepiness or hallucinations (hepatic encephalopathy)
Sudden collapse with fatigue
Jaundice
Swelling of the abdomen
Prolonged nausea and vomiting can cause dehydration. If you have been vomiting repeatedly, you may notice these symptoms:
Feeling tired or weak
Feeling confused or having difficulty concentrating
Headache
Not urinating
Irritability
Symptoms of liver failure may include the following:
Fluid retention causing swelling of the belly (ascites) and sometimes the legs
Weight gain due to ascites
Persistent jaundice
Loss of appetite, weight loss, wasting
Vomiting with blood in the vomit
Bleeding from the nose, mouth, or rectum or blood in the stool
Hepatic encephalopathy (excessive sleepiness, mental confusion, and in advanced stages, development of coma)
Call your health care provider if you have any of the following:
Nausea and vomiting that does not go away in 1-2 days
Yellow skin or eyes
Dark-colored urine (like tea or cola)
Pain in the abdomen
Either of these situations also warrants a call to your health care provider:
You think that you might have been exposed to someone with hepatitis or that you might be at risk for any reason.
You have other medical problems and think that you might have hepatitis.
Hepatitis C symptoms:
Basically the first signs are like the others in early stages flu-like;
Slight fatigue
Nausea or poor appetite
Muscle and joint pains
Tenderness in the area of your liver
In the event you develop chronic hepatitis C then you possibly may have some of the following symptoms earlier or develop them later on or not at all;
Fatigue
Lack of appetite
Nausea and vomiting
Persistent or recurring yellowing of your skin and eyes (jaundice)
Low-grade fever
Hepatitis C can still be communicable even if you aren't having symptoms yourself. It can also damage your liver without you being symptomatic too. This is why it is very important to tested at the earliest convenience if you are someone that could have been exposed at any of those clinics. Especially since this alert has been issued.
These clinics will have there day in court. There are already many lawyer firms offering free consultations for those that were treated at the Nevada Clinics during the time in question. All you need to do is an internet search for Hepatitis Malpractice Lawyer, Endoscopy Center Patient, Nevada Endoscopy Lawyer, or even just Nevada Hepatitis C Clinic. It will bring you a list of lawyers ready to assist you in your case. I hope all of you who were exposed get checked and are okay. I also hope you get the justice you deserve for all the pain and suffering that the Clinics are putting you and your families through. My best wishes to you.
HIV
HepB
HepC
The contamination was mainly due to syringes being contaminated by a patients blood borne disease. These would have then been injected into the vials that they were obviously re-using. Which were suppose to be single patient use only vials. Then the medication would be withdrawn once more from that vial and used on a new patient. Thus putting that patient at risk of a variety of diseases:HIV, Hepatitis B, and Hepatitis C. Symptoms of any of these diseases may not show up for years. Therefore, even if it was in 2004 that you used the clinic's services it is very important that you still get checked.
Symptoms for HIV are:
Flu like symptoms for the first 3-6 wks;
Between 2-10 yrs later you will develop any of the following number of symptoms;
Lack of energy
Weight loss
Frequent fevers and sweats
A thick, whitish coating of the tongue or mouth (thrush) that is caused by a yeast infection and sometimes accompanied by a sore throat
Severe or recurring vaginal yeast infections
Chronic pelvic inflammatory disease or severe and frequent infections like herpes zoster
Periods of extreme and unexplained fatigue that may be combined with headaches, lightheadedness, and/or dizziness
Rapid loss of more than 10 pounds of weight that is not due to increased physical exercise or dieting
Bruising more easily than normal
Long-lasting bouts of diarrhoea
Swelling or hardening of glands located in the throat, armpit, or groin
Periods of continued, deep, dry coughing
Increasing shortness of breath
The appearance of discoloured or purplish growths on the skin or inside the mouth
Unexplained bleeding from growths on the skin, from mucous membranes, or from any opening in the body
Recurring or unusual skin rashes
Severe numbness or pain in the hands or feet, the loss of muscle control and reflex, paralysis or loss of muscular strength
An altered state of consciousness, personality change, or mental deterioration
Children may grow slowly or fall sick frequently. HIV positive persons are also found to be more vulnerable to some cancers.
Symptoms for Hepatitis B:
One half of people infected will symptom free;
Others will have flu-like symptoms within 1-6 months with any of the following symptoms;
Appetite loss
Feeling tired (fatigue)
Nausea and vomiting
Itching all over the body
Pain over the liver (on the right side of the abdomen, under the lower rib cage)
Jaundice - A condition in which the skin and the whites of the eyes turn yellow in color
Urine becomes dark in color (like cola or tea).
Stools are pale in color (grayish or clay colored).
Many types of acute viral hepatitis have similar symptoms (hepatitis A, hepatitis C).
Fulminant hepatitis is an unusual illness. It is a severe form of acute hepatitis that can be life threatening if not treated right away. The symptoms develop very suddenly.
Mental disturbances such as confusion, lethargy, extreme sleepiness or hallucinations (hepatic encephalopathy)
Sudden collapse with fatigue
Jaundice
Swelling of the abdomen
Prolonged nausea and vomiting can cause dehydration. If you have been vomiting repeatedly, you may notice these symptoms:
Feeling tired or weak
Feeling confused or having difficulty concentrating
Headache
Not urinating
Irritability
Symptoms of liver failure may include the following:
Fluid retention causing swelling of the belly (ascites) and sometimes the legs
Weight gain due to ascites
Persistent jaundice
Loss of appetite, weight loss, wasting
Vomiting with blood in the vomit
Bleeding from the nose, mouth, or rectum or blood in the stool
Hepatic encephalopathy (excessive sleepiness, mental confusion, and in advanced stages, development of coma)
Call your health care provider if you have any of the following:
Nausea and vomiting that does not go away in 1-2 days
Yellow skin or eyes
Dark-colored urine (like tea or cola)
Pain in the abdomen
Either of these situations also warrants a call to your health care provider:
You think that you might have been exposed to someone with hepatitis or that you might be at risk for any reason.
You have other medical problems and think that you might have hepatitis.
Hepatitis C symptoms:
Basically the first signs are like the others in early stages flu-like;
Slight fatigue
Nausea or poor appetite
Muscle and joint pains
Tenderness in the area of your liver
In the event you develop chronic hepatitis C then you possibly may have some of the following symptoms earlier or develop them later on or not at all;
Fatigue
Lack of appetite
Nausea and vomiting
Persistent or recurring yellowing of your skin and eyes (jaundice)
Low-grade fever
Hepatitis C can still be communicable even if you aren't having symptoms yourself. It can also damage your liver without you being symptomatic too. This is why it is very important to tested at the earliest convenience if you are someone that could have been exposed at any of those clinics. Especially since this alert has been issued.
These clinics will have there day in court. There are already many lawyer firms offering free consultations for those that were treated at the Nevada Clinics during the time in question. All you need to do is an internet search for Hepatitis Malpractice Lawyer, Endoscopy Center Patient, Nevada Endoscopy Lawyer, or even just Nevada Hepatitis C Clinic. It will bring you a list of lawyers ready to assist you in your case. I hope all of you who were exposed get checked and are okay. I also hope you get the justice you deserve for all the pain and suffering that the Clinics are putting you and your families through. My best wishes to you.
HIV
HepB
HepC
Tuesday, March 4, 2008
The Latest On Dirty Vials:
The Nevada State Health Officials shut down The Endoscopy Center Of Southern Nevada in conjunction with it's reuse of vials/syringes. They definitely state that it was "reused anesthesia vials"(syringes, have not been determined as of yet). There were roughly 40,000 patients potentially exposed between March 2004 and January 11,2008. The Health Department was unable to locate everyone due to not having updated addresses. Therefore, they had to take an ad out in the paper. The have set aside funds and a place for the exposed population the their families to be tested for Hepatitis B, Hepatitis C and HIV.
It has been said that this is the largest number exposure, at one time, for such an situation occurring. I still say, that it was out of pure laziness, or else people trying to cheat insurance companies (by cutting a few cents but still charging for the "new price" just the same). It was a total "should never have occurred incident." And for me being in the Medical Field for thirty years I would never work for a place that would ask me to do such a thing. That is definitely putting patients at "risk!"
The State Officials are saying this is "only the tip of the iceberg" as they have another endoscopy clinic under investigation now. This second clinic is associated with the previous one above, it's called Desert Shadow Endoscopy Center. At Desert Shadow no patients have been notified at this time. It has been found that no syringes were ever reused, however "anesthetic vials were reused."
The Endoscopy Center Of Southern Nevada did release a statement in the Las Vegas Sun.
"On behalf of the Endoscopy Center of Southern Nevada, we want to express our deep concern about this incident to the many patients who have put their trust in us over the years. As always, our patients remain our primary responsibility and we have already corrected the situation.
The recent events related to the Southern Nevada Health District study mark the first time anything like this has ever happened at our facility. We have already taken steps to ensure that it will never happen again.
The health district began its investigation in January, and we have been fully cooperating with them. We were officially notified by the health district on February 6, 2008 and submitted our detailed Plan of Correction on February 15, 2008. All concerns noted by the health department were addressed immediately.
We wish to emphasize that the actual risk of anyone being affected by this is extremely low, but as a precaution, anyone who has undergone procedures at the Endoscopy Center who required anesthesia should be tested.
As I’m sure you understand this situation brings with it a number of complex elements including patient privacy and regulatory guidelines. At this time, our counsel has asked that we limit our comments to this statement, and we are unable to take questions.
Thank you."
I edited parts of the above statement released, to the Las Vegas Sun, from the Endoscopy Center Of Southern Nevada. If you are interested you can read it in it's entirely on the link provided below. You can also read comments made by the locals from the community and those who have gone to either one of the Endoscopy centers that have reused the vials.
abcnews.go.com
www.lasvegassun.com
It has been said that this is the largest number exposure, at one time, for such an situation occurring. I still say, that it was out of pure laziness, or else people trying to cheat insurance companies (by cutting a few cents but still charging for the "new price" just the same). It was a total "should never have occurred incident." And for me being in the Medical Field for thirty years I would never work for a place that would ask me to do such a thing. That is definitely putting patients at "risk!"
The State Officials are saying this is "only the tip of the iceberg" as they have another endoscopy clinic under investigation now. This second clinic is associated with the previous one above, it's called Desert Shadow Endoscopy Center. At Desert Shadow no patients have been notified at this time. It has been found that no syringes were ever reused, however "anesthetic vials were reused."
The Endoscopy Center Of Southern Nevada did release a statement in the Las Vegas Sun.
"On behalf of the Endoscopy Center of Southern Nevada, we want to express our deep concern about this incident to the many patients who have put their trust in us over the years. As always, our patients remain our primary responsibility and we have already corrected the situation.
The recent events related to the Southern Nevada Health District study mark the first time anything like this has ever happened at our facility. We have already taken steps to ensure that it will never happen again.
The health district began its investigation in January, and we have been fully cooperating with them. We were officially notified by the health district on February 6, 2008 and submitted our detailed Plan of Correction on February 15, 2008. All concerns noted by the health department were addressed immediately.
We wish to emphasize that the actual risk of anyone being affected by this is extremely low, but as a precaution, anyone who has undergone procedures at the Endoscopy Center who required anesthesia should be tested.
As I’m sure you understand this situation brings with it a number of complex elements including patient privacy and regulatory guidelines. At this time, our counsel has asked that we limit our comments to this statement, and we are unable to take questions.
Thank you."
I edited parts of the above statement released, to the Las Vegas Sun, from the Endoscopy Center Of Southern Nevada. If you are interested you can read it in it's entirely on the link provided below. You can also read comments made by the locals from the community and those who have gone to either one of the Endoscopy centers that have reused the vials.
abcnews.go.com
www.lasvegassun.com
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