Divalproex Sodium Tablet, Extended Release
FDA Recall NDC 55111-533
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Divalproex Sodium (NDC 55111-533). A significant event, classified as Class II, was initiated on Jan 31, 2019 by Dr. Reddy's Laboratories Ltd. The reported reason for this action was: "Failed Dissolution Specifications: Out of specification results observed for high dissolution."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Failed Dissolution Specifications: Out of specification results observed for high dissolution.
Jan 31, 2019
Feb 27, 2019
10,656 bottles
Recall Profile & Regulatory Data
Event ID
82085
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S.A. Nationwide
Termination Date
Feb 14, 2023
Product Description
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
Affected Packages Involved in this Recall
55111-533-30Product
55111-533-60Product
55111-533-01Product
55111-533-05Product
55111-533-79Product
55111-533-78Product
May 2015 Class II Recall: Failed Dissolution Specifications; exceeded specification at the 9 hour time point
Recall Number
Class II Terminated
Failed Dissolution Specifications; exceeded specification at the 9 hour time point
May 22, 2015
Jun 24, 2015
100 count 7479; 500 count - 2544
Recall Profile & Regulatory Data
Event ID
71374
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Apr 24, 2017
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
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
Affected Packages Involved in this Recall
55111-533-30Product
55111-533-60Product
55111-533-01Product
55111-533-05Product
55111-533-79Product
55111-533-78Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
