Mesalamine Delayed-Release Tablets, USP 1.2 g per tablet, Rx Only, 120 Tablets p Supply Disruption — SUN PHARMACEUTICAL INDUSTRIES
Mesalamine Delayed-Release Tablets, USP 1.2 g per tablet, Rx Only, 120 Tablets p Supply Disruption — SUN PHARMACEUTICAL INDUSTRIES is one of 9,000 drug supply records in the DrugSupply dataset. Key details — Drug name: Mesalamine Delayed-Release Tablets, USP 1.2 g per tablet, Rx Only, 120 Tablets p; Manufacturer: SUN P
| Drug name | Mesalamine Delayed-Release Tablets, USP 1.2 g per tablet, Rx Only, 120 Tablets p |
|---|---|
| Manufacturer | SUN PHARMACEUTICAL INDUSTRIES INC |
| Recall/Disruption reason | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. |
| Risk classification | Moderate Risk — Temporary Health Consequence |
| Status | Completed |
| Record type | Enforcement/Recall |
| Recall number | D-0268-2024 |
| Initiation date | 20240118 |
| Quantity affected | 10,690 bottles |
| Dosage form | Drugs |
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