May 2023 FDA Recall Extended Phenytoin Sodium by Amneal Pharmaceuticals Of New York, Llc
D-0876-2023 - Failed Dissolution Specifications
This Class II drug recall was voluntarily initiated by Amneal Pharmaceuticals Of New York, Llc on May 30, 2023 for the product Extended Phenytoin Sodium. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed in LA, PA and OH. and the recall is currently terminated.
Recall Number: D-0876-2023
Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
05-30-2023
06-21-2023
9,056 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.
LA, PA and OH.
06-10-2025
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Distributed by: Amneal Pharmaceuticals LLC., Bridgewater, NJ 08807, NDC 65162-212-10.
Batch or Lot Expiration Information
Lot# HL00721A, Exp. 12/2023
