FDAFDA · Food and drugs·Recall number D-0914-2023
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
Published July 19, 2023 · Recall initiated: July 10, 2023
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- TIAGABINE HYDROCHLORIDE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Distributor
- Distributed nationwide in the USA.
- UPC
- 0362756200838
- Lot
- Lot HAC3339A, Expires 07/2023
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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