D-0393-2022 Class II Terminated
FDA drug recall D-0393-2022 was initiated by Ascend Laboratories, LLC on Jan 12, 2022 and is designated Class II. Reason for recall: Failed Dissolution Specifications. The recall status is terminated (terminated May 31, 2023). Affected quantity: 9216 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 2, 2022
- Initiation Date
- Jan 12, 2022
- Termination Date
- May 31, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9216 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 Specifications.
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: 21143093, Exp. March 2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0393-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026