D-1362-2022 Class II Terminated
FDA drug recall D-1362-2022 was initiated by Amneal Pharmaceuticals of New York, LLC on July 27, 2022 and is designated Class II. Reason for recall: Failed dissolution specifications. The recall status is terminated (terminated August 17, 2023). Affected quantity: 4,309 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- August 31, 2022
- Initiation Date
- July 27, 2022
- Termination Date
- August 17, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,309 bottles
Product Description
Divalproex Sodium Extended Release Tablets, USP, 250 mg, packaged in 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals, India, Distributed by: Amneal Pharmaceuticals, Bridgewater, NJ, NDC 65162-755-10
Reason for Recall
Failed dissolution specifications.
Distribution Pattern
USA nationwide
Code Information
Lot #: AR210705, Exp 04/2024