Drug recall D-0325-2019
Product
Valsartan Tablets, USP 80 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5813-77.
Reason for recall
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Lots and codes
Lot Numbers: 3065445, 3074880, 3074883, 3086688, 3086689, 3086710
Recall details
- Recalling firm
- Mylan Laboratories Limited, (Nashik FDF), Sinnar, Nashik District, N/A
- Quantity
- 119,761 HDPE bottles
- Distribution
- Product was distributed throughout the United States to several major distributors, including Puerto Rico.
- Type
- Voluntary: Firm initiated
- Recall initiated
- December 4, 2018
Related products
- Valsartan – drug information
- NDC 0378-5815 Valsartan · Valsartan 320 mg/1 · Mylan Pharmaceuticals Inc.
- NDC 0378-5813 Valsartan · Valsartan 80 mg/1 · Mylan Pharmaceuticals Inc.
- NDC 0378-5814 Valsartan · Valsartan 160 mg/1 · Mylan Pharmaceuticals Inc.
- NDC 0378-5807 Valsartan · Valsartan 40 mg/1 · Mylan Pharmaceuticals Inc.