MYCOPHENOLATE SODIUM Recall D-0668-2024
Description: Mycophenolic Acid Delayed-Release Tablets USP, 360 mg, Rx Only, 120 Tablets per bottle, Manufactured by Alkem Laboratories, LTD, INDIA; Distributed by Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-427-12.
MYCOPHENOLATE SODIUM Recall D-0668-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0668-2024 |
| Event ID | 95275 |
| Brand | MYCOPHENOLIC ACID |
| Generic Name | MYCOPHENOLIC ACID |
| Manufacturer | MYCOPHENOLIC ACID |
| Original Package? | 1 |
| Active Substance | MYCOPHENOLATE SODIUM |
| Drug Route | ORAL |
| Distribution | Nationwide in the USA and PR |
| Quantity | 117,493 bottles |
| Recall Reason | Failed Dissolution Specifications |
| Drug Classification | Class II |
| Drug Code Info | 20241002 |
| Product NDC | 67877-426 67877-427 |
| Drug UPC | 0367877427126 |
| Recall Initiation Date | 20240903 |
| Report Date | 20241002 |
| Classification Date | 20240924 |
| Address | 339 Jefferson Rd Ste 101 Parsippany, NJ 07054-3707 United States |
| Recalling Firm | Ascend Laboratories, LLC |
| Initial Notification | Letter |
| Unique Ingredient Identifier | WX877SQI1G |
| Drug Application Number | ANDA208315 |
| Structured Product Labeling (SPL ID) | 3e021c3e-6b9c-41a2-987a-e6c60e3c4cf3 |
| Structured Product Labeling (SPL Set ID) | 2d9975e1-baee-4b0c-83de-8a0a92c5d075 |
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