Drug 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.
D-0313-2019
Product summary
- Event
- Event 81613
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 24,709 bottles
- Official record key
drug-enforcement:D-0313-2019
Official wording
Reason: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Code information: Lot # 3063782, exp. date 1/2019
Distribution pattern: Product was distributed throughout the United States.
Derived failure modes
-
Foreign material or chemical contamination
impurity, N-nitrosodiethylamine (NDEA
-
Manufacturing or process control
CGMP Deviations