Divalproex Sodium Tablet, Extended Release
FDA Recall NDC 55111-534
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Divalproex Sodium (NDC 55111-534). A significant event, classified as Class II, was initiated on May 22, 2015 by Dr. Reddy's Laboratories Ltd. The reported reason for this action was: "Failed Dissolution Specifications; exceeded specification at the 9 hour time point"
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
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
5,160 bottles
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, 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
55111-534-30Product
55111-534-60Product
55111-534-01Product
55111-534-05Product
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.
