MESALAMINE Recall D-0268-2024
Description: Mesalamine Delayed-Release Tablets, USP 1.2 g per tablet, Rx Only, 120 Tablets per bottle, Once Daily, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191 (U.T. of D & NH), INDIA, NDC 63304-175-13.
MESALAMINE Recall D-0268-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0268-2024 |
| Event ID | 93820 |
| Brand | MESALAMINE |
| Generic Name | MESALAMINE |
| Manufacturer | MESALAMINE |
| Original Package? | 1 |
| Active Substance | MESALAMINE |
| Drug Route | ORAL |
| Distribution | Nationwide in the USA |
| Quantity | 10,690 bottles |
| Recall Reason | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. |
| Drug Classification | Class II |
| Drug Code Info | 20240131 |
| Product NDC | 63304-175 |
| Product NUI | N0000175781 M0000971 |
| Pharma Class (EPC) | Aminosalicylate [EPC] |
| Pharma Class (CS) | Aminosalicylic Acids [CS] |
| Recall Initiation Date | 20240118 |
| Report Date | 20240131 |
| Classification Date | 20240125 |
| Address | 2 Independence Way Princeton, NJ 08540-6620 United States |
| Recalling Firm | SUN PHARMACEUTICAL INDUSTRIES INC |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 4Q81I59GXC |
| Drug Application Number | ANDA211858 |
| Structured Product Labeling (SPL ID) | 3f29d761-eab5-4f6b-a4f4-ffcc072648e3 |
| Structured Product Labeling (SPL Set ID) | fd8b02de-7dfa-444d-a1f8-1436b578e0cb |
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