Recall: D-0090-2024

Class II - Potentially Harmful

Class IIClassification

2023-10-27Initiated

TerminatedStatus

Amneal Pharmaceuticals of New Firm

Product

Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater, NJ, 08807, NDC# 65162-212-10

Reason

Failed Dissolution Specifications

Distribution

Nationwide in the USA and Puerto Rico

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