Recall: D-0876-2023

Class II - Potentially Harmful

Class IIClassification

2023-05-30Initiated

TerminatedStatus

Amneal Pharmaceuticals of New Firm

Product

Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Distributed by: Amneal Pharmaceuticals LLC., Bridgewater, NJ 08807, NDC 65162-212-10.

Reason

Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)

Distribution

LA, PA and OH.

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