FDA-Drug2023-07-19Class II
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
SUN PHARMACEUTICAL INDUSTRIES INC
Hazard
Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing
Sold states
Distributed nationwide in the USA.
Affected count
8,880 30-count bottles
Manufactured in
2 Independence Way, N/A, Princeton, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0914-2023Don't want to check this manually?
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