FDA recall D-0426-2024

Amneal Pharmaceuticals of New York, LLC · Class II · drug

Product

Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 65162-755-10. NDC# 65162-755-10

Reason for recall

Failed dissolution specifications

Distribution

Product was distributed nationwide.

Key facts

Status: Terminated
Initiation date: 2023-12-26
Report date: 2024-04-03
Termination date: 2024-08-16
Voluntary/Mandated: Voluntary: Firm initiated
Location: Brookhaven, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0426-2024