Drug recall D-0315-2019
Product
Valsartan Tablets, USP, 40 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-5807-93.
Reason for recall
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Lots and codes
Lot # 3061169, exp. date 11/2018
Recall details
- Recalling firm
- Mylan Pharmaceuticals Inc., Morgantown, WV
- Quantity
- 63,213 bottles
- Distribution
- Product was distributed throughout the United States.
- Type
- Voluntary: Firm initiated
- Recall initiated
- November 20, 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.