• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of June 24, 2015

  • Print
  • Share
  • E-mail
-

Product Detail

Product Description 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
Recall Number D-1135-2015
Classification Class II
Code Info 100 count bottle - Lot #C307859, exp 09/2015; 500 count bottle - Lot #C307859 and Lot# C307812, exp 09/2015
Product Distributed Qty 100 count 7479; 500 count - 2544
Reason For Recall Failed Dissolution Specifications; exceeded specification at the 9 hour time point

Event Detail

Event Id 71374
Product Type Drugs
Status Ongoing
Recalling Firm Dr. Reddy's Laboratories, Inc.
City Princeton
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2015-05-22
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide
-
-