Tiagabine Hydrochloride Tablet, Film Coated
FDA Recall NDC 62756-224
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 Tiagabine Hydrochloride (NDC 62756-224). A significant event, classified as Class II, was initiated on Jul 10, 2023 by Sun Pharmaceutical Industries, Inc.. The reported reason for this action was: "Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing"
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 Impurities: Out of Specification (OOS) result observed during Related Substances testing
Jul 10, 2023
Jul 19, 2023
8,880 30-count bottles
Recall Profile & Regulatory Data
Event ID
92671
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed nationwide in the USA.
Termination Date
Dec 18, 2023
Product Description
Tiagabine Hydrochloride Tablets, 2 mg, 30-count bottle, Distributed by Sun Pharmaceutical Industries. Inc. Cranbury NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Halol-Baroda Highway, Halol-389 350, Gujarat, India. NDC#: 62756-200-83
Batch or Lot Expiration Information
Lot# Lot HAC3339A, Expires 07/2023
Affected Packages Involved in this Recall
62756-200-83Product
62756-200-18Product
62756-224-83Product
62756-224-88Product
62756-224-08Product
62756-224-18Product
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.
