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
- Company Announcement Date:
- November 20, 2018
- FDA Publish Date:
- November 20, 2018
- Reason for Announcement:
Recall Reason DescriptionDue to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine)
- Company Name:
- Mylan Pharmaceuticals
- Brand Name:
- Product Description:
Product DescriptionAmlodipine and Valsartan Tablets; Valsartan Tablets; Valsartan and Hydrochlorothiazide Tablets
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.
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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