Divalproex Sodium Tablet, Extended Release
FDA Recall NDC 0904-6363
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 0904-6363). A significant event, classified as Class II, was initiated on Apr 24, 2019 by Major Pharmaceuticals. The reported reason for this action was: "cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations."
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
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
Apr 24, 2019
Aug 07, 2019
828 100-count unit dose cartons
Recall Profile & Regulatory Data
Event ID
83460
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
MAJOR PHARMACEUTICALS
Voluntary / Mandated
N/A
Distribution Pattern
Nationwide in the USA
Termination Date
Jul 16, 2020
Product Description
DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP Tablets, 250 mg, 100 count-unit dose carton, RX only, Manufactured by Dr. Reddy's Laboratories Ltd. Bachupally - 500 090 India. Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152. NDC # 0904-6363-61.
Batch or Lot Expiration Information
Lot# M02250 EXP 10/2020.
Affected Packages Involved in this Recall
0904-6363-45Product
0904-6363-61Product
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.
