Carvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by: Gl Supply Disruption — Glenmark Pharmaceuticals Inc.
Carvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by: Gl Supply Disruption — Glenmark Pharmaceuticals Inc. is one of 9,000 drug supply records in the DrugSupply dataset. Key details — Drug name: Carvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by: Gl; Manufacturer: Glenm
| Drug name | Carvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by: Gl |
|---|---|
| Manufacturer | Glenmark Pharmaceuticals Inc., USA |
| Recall/Disruption reason | CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level. |
| Risk classification | Moderate Risk — Temporary Health Consequence |
| Status | Ongoing |
| Record type | Enforcement/Recall |
| Recall number | D-0578-2025 |
| Initiation date | 20250807 |
| Quantity affected | 6,432 bottles |
| Dosage form | Drugs |
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