Recall: D-1362-2022

Class II - Potentially Harmful

Class IIClassification

2022-07-27Initiated

TerminatedStatus

Amneal Pharmaceuticals of New Firm

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

Failed dissolution specifications.

Distribution

USA nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.