Recalls / Class II
Class IID-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
- Brand name
- Tiagabine Hydrochloride
- Generic name
- Tiagabine Hydrochloride
- Active ingredient
- Tiagabine Hydrochloride
- Route
- Oral
- NDCs
- 62756-200, 62756-224
- FDA application
- ANDA077555
- Affected lot / code info
- Lot HAC3339A, Expires 07/2023
Why it was recalled
Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing
Recalling firm
- Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Independence Way, N/A, Princeton, New Jersey 08540-6620
Distribution
- Quantity
- 8,880 30-count bottles
- Distribution pattern
- Distributed nationwide in the USA.
Timeline
- Recall initiated
- 2023-07-10
- FDA classified
- 2023-07-11
- Posted by FDA
- 2023-07-19
- Terminated
- 2023-12-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0914-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.