December 2023 FDA Recall Divalproex Sodium by Amneal Pharmaceuticals Of New York, Llc
D-0426-2024 - Failed dissolution specifications

This Class II drug recall was voluntarily initiated by Amneal Pharmaceuticals Of New York, Llc on December 26, 2023 for the product Divalproex 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-0426-2024

Reason for Recall
Failed dissolution specifications
Initiated
12-26-2023
Reported
04-03-2024
Quantity
21,452/100 count bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93976
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
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.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-16-2024
Product Description About Product Description
Full technical description of the product.
Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 65162-755-10. NDC# 65162-755-10

Batch or Lot Expiration Information

Lot# AR210704, exp. date 04/2024 AR210706, exp. date 04/2024 AR210707, exp. date 04/2024 AR210708, exp. date 04/2024 AR210709, exp. date 04/2024

Affected Packages Involved in this Recall

65162-755-10 Divalproex Sodium
65162-755-50 Divalproex Sodium
65162-757-10 Divalproex Sodium
65162-757-50 Divalproex Sodium