Drug product
Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 40 mg, 30 Tablets Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited Unit V, Polepally Jadcherla Mahaboob Nagar - 509-301, India. NDC 31722-745-30 UPC 331722745307
D-1113-2018
Product summary
- Event
- Event 80773
- Status
- Completed
- Classification
- Class II
- Quantity
- 316,380 bottles
- Official record key
drug-enforcement:D-1113-2018
Official wording
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Code information: All Lots with expiration dates 7/2018 to 6/2020
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations