January 2019 FDA Recall Divalproex Sodium by Dr. Reddy's Laboratories, Inc.
D-0507-2019 - Failed Dissolution Specifications
This Class II drug recall was voluntarily initiated by Dr. Reddy's Laboratories, Inc. on January 31, 2019 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-0507-2019
Failed Dissolution Specifications: Out of specification results observed for high dissolution.
01-31-2019
02-27-2019
10,656 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.
Dr. Reddy's Laboratories, Inc.
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.
U.S.A. Nationwide
02-14-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Divalproex Sodium Extended-release Tablets, USP 250 mg, 100-count bottle, Rx only, Mfd.By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 India NDC 55111-533-01
Batch or Lot Expiration Information
Lot# : C802676, Exp 03/20
