chlorproMAZINE Hydrochloride Tablets, USP 10 mg, Rx Only, 100 Tablets bottles, M Supply Disruption — Zydus Pharmaceuticals (USA) I
chlorproMAZINE Hydrochloride Tablets, USP 10 mg, Rx Only, 100 Tablets bottles, M Supply Disruption — Zydus Pharmaceuticals (USA) I is one of 9,000 drug supply records in the DrugSupply dataset. Key details — Drug name: chlorproMAZINE Hydrochloride Tablets, USP 10 mg, Rx Only, 100 Tablets bottles, M; Manufacturer: Zydus
| Drug name | chlorproMAZINE Hydrochloride Tablets, USP 10 mg, Rx Only, 100 Tablets bottles, M |
|---|---|
| Manufacturer | Zydus Pharmaceuticals (USA) Inc |
| Recall/Disruption reason | CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit |
| Risk classification | Moderate Risk — Temporary Health Consequence |
| Status | Ongoing |
| Record type | Enforcement/Recall |
| Recall number | D-0361-2025 |
| Initiation date | 20250403 |
| Quantity affected | 3144 bottles, pack size: 100's Count |
| Dosage form | Drugs |
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