Drug product
Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-1724-93.
D-0318-2019
Product summary
- Event
- Event 81613
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 48,302 bottles
- Official record key
drug-enforcement:D-0318-2019
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 # 3061986, exp. date 11/2018 Lot # 3079709, exp. date 1/2020 Lot # 3077618, exp. date 11/2019 Lot # 3079708, exp. date 1/2020
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