AvKARE Valsartan and Hydrochlorothiazide 160 mg/25 mg tablets, 90-count bottle, Supply Disruption — Avkare Incorporated (Moderate
AvKARE Valsartan and Hydrochlorothiazide 160 mg/25 mg tablets, 90-count bottle, Supply Disruption — Avkare Incorporated (Moderate is one of 9,000 drug supply records in the DrugSupply dataset. Key details — Drug name: AvKARE Valsartan and Hydrochlorothiazide 160 mg/25 mg tablets, 90-count bottle,; Manufacturer: Avkare
| Drug name | AvKARE Valsartan and Hydrochlorothiazide 160 mg/25 mg tablets, 90-count bottle, |
|---|---|
| Manufacturer | Avkare Incorporated |
| 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-1175-2018 |
| Initiation date | 20180718 |
| Quantity affected | 19109 bottles |
| Dosage form | Drugs |
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