Drug 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
D-0914-2023
Product summary
- Event
- Event 92671
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8,880 30-count bottles
- Official record key
drug-enforcement:D-0914-2023
Official wording
Reason: Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing
Code information: Lot HAC3339A, Expires 07/2023
Distribution pattern: Distributed nationwide in the USA.
Derived failure modes
-
Potency or specification failure
Out of Specification