D-0169-2023 Class II Terminated
FDA drug recall D-0169-2023 was initiated by Ascend Laboratories, LLC on January 5, 2023 and is designated Class II. Reason for recall: Failed Dissolution Specification The recall status is terminated (terminated August 15, 2024). Affected quantity: 49,632 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- February 1, 2023
- Initiation Date
- January 5, 2023
- Termination Date
- August 15, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 49,632 bottles
Product Description
Metoprolol Succinate Extended-Release Tablets, USP 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany NJ 07054, NDC 67877-590-01.
Reason for Recall
Failed Dissolution Specification
Distribution Pattern
Nationwide and Puerto Rico
Code Information
Lot #s: 21143094, 21143095, 21143119, 21143121, 21142389, Exp 03/31/2023.