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FDARecalled Jul 19, 2023 · #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 Hig...

Hazard

Class II — temporary health risk

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Description

Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing Classification: Class II Distribution: Distributed nationwide in the USA.

Product details

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
Type
Drugs
Manufacturer
SUN PHARMACEUTICAL INDUSTRIES INC
Model numbers
HAC3339A
UPCs