Multi-event May 2015 FDA Recall Divalproex Sodium by Dr. Reddy's Laboratories, Inc.
This Multi-event Class II drug recall was voluntarily initiated by Dr. Reddy's Laboratories, Inc. on May 22, 2015 for the product Divalproex Sodium. The FDA reported the reason for recall as failed dissolution specifications; exceeded specification at the 9 hour time point. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-1136-2015
Failed Dissolution Specifications; exceeded specification at the 9 hour time point
05-22-2015
06-24-2015
5,160 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.
Nationwide
04-24-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Divalproex Sodium Extended-Release Tablets, USP, 500 mg, 100 count bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories Limited Bachupally 500 090 India --- NDC 55111-534-01
Batch or Lot Expiration Information
Lot# C308195, exp 10/2015
Affected Packages Involved in this Recall
Recall Number: D-1135-2015
Failed Dissolution Specifications; exceeded specification at the 9 hour time point
05-22-2015
06-24-2015
100 count 7479; 500 count - 2544
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.
Nationwide
04-24-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Divalproex Sodium Extended-Release Tablets, USP, (valproic acid activity), 250 mg, 100 count (NDC 55111-533-01) and 500 count (NDC 55111-533-05) bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories Limited, Bachupally 500 090 India
Batch or Lot Expiration Information
Lot# 100 count bottle -
Lot# C307859, exp 09/2015; 500 count bottle -
Lot# C307859 and
Lot# C307812, exp 09/2015
