D-0914-2023 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 19, 2023
- Initiation Date
- July 10, 2023
- Termination Date
- December 18, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,880 30-count bottles
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
Reason for Recall
Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing
Distribution Pattern
Distributed nationwide in the USA.
Code Information
Lot HAC3339A, Expires 07/2023