SUN PHARMACEUTICAL INDUSTRIES INC recalls Tiagabine Hydrochloride Tablets, 2 mg, 30-count bottle, Distributed by Sun Pharmaceutical Industries. Inc. Cranbury NJ 0
Recalled July 19, 2023 · FDA recall D-0914-2023 · SUN PHARMACEUTICAL INDUSTRIES
Hazard
Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing · FDA Class II
Units
8,880 30-count bottles
Sold at
Distributed nationwide in the USA.
Description
Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing
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
Manufacturer(s)
SUN PHARMACEUTICAL INDUSTRIES INC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →