Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Distributed by...
FDA Recall #D-0876-2023 — Class II — May 30, 2023
Product Description
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 for Recall
Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
Recalling Firm
Amneal Pharmaceuticals of New York, LLC — Brookhaven, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
9,056 bottles
Distribution
LA, PA and OH.
Code Information
Lot # HL00721A, Exp. 12/2023
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated