MESALAMINE Recall D-0350-2024
Description: Mesalamine Extended-Release Capsules, USP 500mg, Rx Only, 120 Capsules per bottle, Manufactured by: Sun Pharmaceutical Industries Limited, Mohali, INDIA, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 63304-089-13.
MESALAMINE Recall D-0350-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0350-2024 |
| Event ID | 93909 |
| Brand | MESALAMINE |
| Generic Name | MESALAMINE |
| Manufacturer | MESALAMINE |
| Original Package? | 1 |
| Active Substance | MESALAMINE |
| Drug Route | ORAL |
| Distribution | Nationwide in the U.S. |
| Quantity | 54,960 bottles |
| Recall Reason | Failed Dissolution Specifications: Out of specification for dissolution. |
| Drug Classification | Class II |
| Drug Code Info | 20240306 |
| Product NDC | 63304-089 |
| Product NUI | N0000175781 M0000971 |
| Drug UPC | 0363304089134 |
| Pharma Class (EPC) | Aminosalicylate [EPC] |
| Pharma Class (CS) | Aminosalicylic Acids [CS] |
| Recall Initiation Date | 20240205 |
| Report Date | 20240306 |
| Classification Date | 20240223 |
| 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 | ANDA214585 |
| Structured Product Labeling (SPL ID) | 1b905f15-0048-41f5-9e39-6bf4d29bce2c |
| Structured Product Labeling (SPL Set ID) | c2f84490-70b8-4998-907d-a77e9f791de1 |
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