FDA recall D-1362-2022

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

Product

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

USA nationwide

Key facts

Status: Terminated
Initiation date: 2022-07-27
Report date: 2022-08-31
Termination date: 2023-08-17
Voluntary/Mandated: Voluntary: Firm initiated
Location: Brookhaven, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1362-2022