Why it was recalled
Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing
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
Lot numbers, UPCs & expiration codes
Lot HAC3339A, Expires 07/2023
Where it was sold
Distributed nationwide in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0914-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 10, 2023
- FDA report date
- Jul 19, 2023
- Quantity
- 8,880 30-count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
Original FDA data
Every field from FDA enforcement report D-0914-2023, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 92671
- Address
- 2 Independence Way
- Code information
- Lot HAC3339A, Expires 07/2023
- Postal code
- 08540-6620
- Report date
- Jul 19, 2023
- Product type
- Drugs
- Recall number
- D-0914-2023
- Classification
- Class II
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Product quantity
- 8,880 30-count bottles
- Termination date
- Dec 18, 2023
- Reason for recall
- Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Distributed nationwide in the USA.
- Recall initiation date
- Jul 10, 2023
- Initial firm notification
- Letter
- Center classification date
- Jul 11, 2023