METOPROLOL SUCCINATE Recall D-0171-2023
Description: Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 500 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany NJ 07054, NDC 67877-591-05.
METOPROLOL SUCCINATE Recall D-0171-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0171-2023 |
| Event ID | 91442 |
| Brand | METOPROLOL SUCCINATE |
| Generic Name | METOPROLOL SUCCINATE ER TABLETS |
| Manufacturer | METOPROLOL SUCCINATE ER TABLETS |
| Original Package? | 1 |
| Active Substance | METOPROLOL SUCCINATE |
| Drug Route | ORAL |
| Distribution | Nationwide and Puerto Rico |
| Quantity | 2628 bottles |
| Recall Reason | Failed Dissolution Specification |
| Drug Classification | Class II |
| Drug Code Info | 20230201 |
| Product NDC | 67877-590 67877-591 67877-592 |
| Drug UPC | 0367877591308 0367877592305 0367877593012 |
| Recall Initiation Date | 20230105 |
| Report Date | 20230201 |
| Classification Date | 20230120 |
| Address | 339 Jefferson Rd Ste 101 Parsippany, NJ 07054-3707 United States |
| Recalling Firm | Ascend Laboratories, LLC |
| Initial Notification | |
| Unique Ingredient Identifier | TH25PD4CCB |
| Drug Application Number | ANDA211143 |
| Structured Product Labeling (SPL ID) | 6f39b794-8b17-4b04-b47c-74a0eb6bf040 |
| Structured Product Labeling (SPL Set ID) | 58441cd3-6043-4bb8-adab-1b32a203bfb2 |
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