Drug product
Valsartan and Hydrochlorothiazide Tablets, USP, 320 mg/25 mg, (a) 500-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A. NDC 0378-6325-05.
D-0317-2019
Product summary
- Event
- Event 81613
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5,660 bottles
- Official record key
drug-enforcement:D-0317-2019
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 # 3084886, exp. date 2/2019 Lot # 3093804, exp. date 12/2019
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