Divalproex Sodium Tablet, Delayed Release
FDA Recall NDC 29300-138
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 29300-138). A significant event, classified as Class II, was initiated on Dec 19, 2017 by Unichem Pharmaceuticals (usa), Inc.. The reported reason for this action was: "Cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalproex Sodium."
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
Cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalproex Sodium.
Dec 19, 2017
Jan 24, 2018
96,876 Bottles of 30s
Recall Profile & Regulatory Data
Event ID
78786
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Unichem Pharmaceuticals Usa Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed nationwide in the USA.
Termination Date
Sep 12, 2018
Product Description
Divalproex Sodium Delayed Release Tablets USP, 500 mg, 100-count bottle, RX Only, Manufactured by: Unichem Laboratories Ltd. Ind. Area, Meerut Road, Ghaziabad-201 003, India. Marketed By: Unichem Pharmaceuticals (USA), Inc. Hasbrouck Heights, NJ 07604. NDC 29300-140-01
Batch or Lot Expiration Information
Lot# Lot: ZDPH17040
Affected Packages Involved in this Recall
29300-138-01Product
29300-138-05Product
29300-138-10Product
29300-139-01Product
29300-139-05Product
29300-139-10Product
29300-140-01Product
29300-140-05Product
29300-140-10Product
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.
