Reported Jul 19, 2023 · Terminated
Tiagabine Hydrochloride Tablets, 2 mg, 30-count bottle, Distributed by Sun Pharmaceutical Industries. Inc. Cranbury NJ…
Sun Pharmaceutical Industries Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SUN PHARMACEUTICAL INDUSTRIES INC · 2 Independence Way · Princeton, NJ · 08540-6620
Is this the product you have?
- Tiagabine Hydrochloride Tablets, 2 mg, 30-count bottle, Distributed by Sun Pharmaceutical Industries. Inc. Cranbury NJ 08512
- Manufactured bySun Pharmaceutical Industries Limited Halol-Baroda Highway, Halol-389 350, Gujarat, India. NDC#: 62756-200-83
- Lot codes and dates
Lot HAC3339AExpires 07/2023
- Amount recalled
- 8,880 30-count bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing
This product could cause temporary or reversible health problems — stop using it.
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