Multi event Drug Recall Enforcement Report Class II voluntary initiated by Bryant Ranch Prepack Inc., originally initiated on 07-27-2018 for the product Valsartan 320 mg tablets, 30-count bottles ( NDC 63629-6905-1), 90-count bottles (NDC 63629-6905-2), 28-count bottles (NDC 6362-96905-3), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504. The product was recalled due to cgmp deviations: carcinogen impurity detected in api used to manufacture drug product.. The product was distributed in Product Was Distributed In Hi, In, And Fl. and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-1028-2018 | 07-27-2018 | 08-08-2018 | Class II | 990 tablets | Valsartan 320 mg tablets, 30-count bottles ( NDC 63629-6905-1), 90-count bottles (NDC 63629-6905-2), 28-count bottles (NDC 6362-96905-3), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504. | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Terminated |
| D-1027-2018 | 07-27-2018 | 08-08-2018 | Class II | 690 tablets | Valsartan 80 mg tablets, 90-count bottles (NDC 63629-6922-2), 60-count bottles ( 63629-6922-3), 28-count bottles (63629-6922-4), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504. | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Terminated |
| D-1029-2018 | 07-27-2018 | 08-08-2018 | Class II | 90 tablets | Valsartan 320 mg tablets, 90-count bottles ( NDC 71335-0567-2), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504. | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Terminated |
Recalled Products
