Verapamil Hydrochloride Tablet, Film Coated, Extended Release
FDA Recall NDC 68462-293
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 Verapamil Hydrochloride (NDC 68462-293). A significant event, classified as Class II, was initiated on Mar 15, 2021 by Glenmark Pharmaceuticals Inc., Usa. The reported reason for this action was: "CGMP Deviations: Intermittent exposure to temperature excursion during storage."
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: Intermittent exposure to temperature excursion during storage.
Mar 15, 2021
Jun 02, 2021
513 bottles
Recall Profile & Regulatory Data
Event ID
87512
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Cardinal Health Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
FL, GA, SC
Termination Date
Jun 17, 2024
Product Description
Verapamil Hydrochloride Extended-Release Tablets USP 120 mg Rx Only NDC 68462-292-01 Manufactured by: Glenmark Generics Ltd Colvale-Bardez, Goa 403513, India Manufactured for: Glenmark Generics Inc., USA Mahwah, NJ 07430
Batch or Lot Expiration Information
Lot# 19205584
Affected Packages Involved in this Recall
68462-292-90Product
68462-292-01Product
68462-292-05Product
68462-293-90Product
68462-293-01Product
68462-293-05Product
68462-260-30Product
68462-260-90Product
68462-260-01Product
68462-260-05Product
68462-260-10Product
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.
