FDA Recall Terminated Historical recordClass II
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
- Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing
- Published
- July 19, 2023
- Distribution
- Nationwide
