July 2023 FDA Recall Tiagabine Hydrochloride by Sun Pharmaceutical Industries Inc
D-0914-2023 - Failed Impurities

This Class II drug recall was voluntarily initiated by Sun Pharmaceutical Industries Inc on July 10, 2023 for the product Tiagabine Hydrochloride. The FDA reported the reason for recall as failed impurities. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0914-2023

Reason for Recall
Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing
Initiated
07-10-2023
Reported
07-19-2023
Quantity
8,880 30-count bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92671
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed nationwide in the USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-18-2023
Product Description About Product Description
Full technical description of the product.
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

62756-200-83 Tiagabine Hydrochloride
62756-200-18 Tiagabine Hydrochloride
62756-224-83 Tiagabine Hydrochloride
62756-224-88 Tiagabine Hydrochloride
62756-224-08 Tiagabine Hydrochloride
62756-224-18 Tiagabine Hydrochloride