Drug recall D-1114-2018
Product
Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 80 mg, 90 count bottles, 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 31722-746-90 UPC 331722746908
Reason for recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Lots and codes
All Lots with expiration dates 7/2018 to 6/2020
Recall details
- Recalling firm
- Hetero Labs Limited Unit V, Jadcherla Mandal, Mahaboob Nagar
- Quantity
- 394,896 bottles
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- August 8, 2018
Related products
- Valsartan – drug information
- NDC 31722-748 Valsartan · Valsartan 320 mg/1 · Camber Pharmaceuticals, Inc.
- NDC 31722-747 Valsartan · Valsartan 160 mg/1 · Camber Pharmaceuticals, Inc.
- NDC 31722-746 Valsartan · Valsartan 80 mg/1 · Camber Pharmaceuticals, Inc.
- NDC 31722-745 Valsartan · Valsartan 40 mg/1 · Camber Pharmaceuticals, Inc.