Valsartan Tablets, USP 40 mg Rx Only NDC 50268-783-15 50 Tablets (5x10) Unit Dos Supply Disruption — AVKARE Inc. (Moderate Risk —
Valsartan Tablets, USP 40 mg Rx Only NDC 50268-783-15 50 Tablets (5x10) Unit Dos Supply Disruption — AVKARE Inc. (Moderate Risk — is one of 9,000 drug supply records in the DrugSupply dataset. Key details — Drug name: Valsartan Tablets, USP 40 mg Rx Only NDC 50268-783-15 50 Tablets (5x10) Unit Dos; Manufacturer: AVKARE
| Drug name | Valsartan Tablets, USP 40 mg Rx Only NDC 50268-783-15 50 Tablets (5x10) Unit Dos |
|---|---|
| Manufacturer | AVKARE Inc. |
| Recall/Disruption reason | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. |
| Risk classification | Moderate Risk — Temporary Health Consequence |
| Status | Terminated |
| Record type | Enforcement/Recall |
| Recall number | D-1130-2018 |
| Initiation date | 20180814 |
| Quantity affected | 6776 cartons (338,800 tablets) |
| Dosage form | Drugs |
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