Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufacture Supply Disruption — Lupin Pharmaceuticals Inc. (L
Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufacture Supply Disruption — Lupin Pharmaceuticals Inc. (L is one of 9,000 drug supply records in the DrugSupply dataset. Key details — Drug name: Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufacture; Manufacturer: Lupin
| Drug name | Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufacture |
|---|---|
| Manufacturer | Lupin Pharmaceuticals Inc. |
| Recall/Disruption reason | Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study. |
| Risk classification | Low Risk — Unlikely to Cause Adverse Health Effects |
| Status | Terminated |
| Record type | Enforcement/Recall |
| Recall number | D-0899-2023 |
| Initiation date | 20230627 |
| Quantity affected | 3,096 bottles |
| Dosage form | Drugs |
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