FDA Recall Valsartan
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The last Recall Enforcement Report for Valsartan with NDC 31722-745 was initiated on 08-08-2018 as a Class II recall due to cgmp deviations: carcinogen impurity detected in api used to manufacture drug product. The latest recall number for this product is D-1113-2018 and the recall is currently completed .
Recall Number | Initiation Date | Report Date | Recall Classification | Product Quantity | Product Description | Status |
---|---|---|---|---|---|---|
D-1113-2018 | 08-08-2018 | 08-29-2018 | Class II | 316,380 bottles | 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 | Completed |
D-1114-2018 | 08-08-2018 | 08-29-2018 | Class II | 394,896 bottles | 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 | Completed |
D-1115-2018 | 08-08-2018 | 08-29-2018 | Class II | 441,408 bottles | Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 160 mg, 90 tablets Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited, Unit V, Pollepally Jadcherla Mahabubnagar - 509-301, India. NDC 31722-747-90 UPC 331722747905 | Completed |
D-1116-2018 | 08-08-2018 | 08-29-2018 | Class II | 441,408 bottles | Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 320 mg, 90 tablets, Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited Unit V, Pollepally Jadcherla Mahaboob Nagar - 509-301 India. NDC 31722-748-90 UPC 331722748902 | Completed |
What is the Enforcement Report?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.