Drug recall D-0914-2023
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
Reason for recall
Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing
Lots and codes
Lot HAC3339A, Expires 07/2023
Recall details
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ
- Quantity
- 8,880 30-count bottles
- Distribution
- Distributed nationwide in the USA.
- Type
- Voluntary: Firm initiated
- Recall initiated
- July 10, 2023
- Terminated
- December 18, 2023
Related products
- Tiagabine Hydrochloride – drug information
- NDC 62756-224 Tiagabine Hydrochloride · Tiagabine Hydrochloride 4 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 62756-200 Tiagabine Hydrochloride · Tiagabine Hydrochloride 2 mg/1 · Sun Pharmaceutical Industries, Inc.