October 2023 FDA Recall Extended Phenytoin Sodium by Amneal Pharmaceuticals Of New York, Llc
D-0090-2024 - Failed Dissolution Specifications
This Class II drug recall was voluntarily initiated by Amneal Pharmaceuticals Of New York, Llc on October 27, 2023 for the product Extended Phenytoin Sodium. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0090-2024
Failed Dissolution Specifications
10-27-2023
11-15-2023
9,263 100-count bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Amneal Pharmaceuticals of New York, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA and Puerto Rico
08-06-2025
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater, NJ, 08807, NDC# 65162-212-10
Batch or Lot Expiration Information
Lot# HM03221A, Exp. date 12/31/2023
