Tiagabine Hydrochloride Tablets…

Date

July 19, 2023

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

Sun Pharmaceutical Industries Inc

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

Reason

Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing

Distribution pattern

Distributed nationwide in the USA.

Quantity

8,880 30-count bottles

Codes and lots

Lot HAC3339A, Expires 07/2023

Recall started

July 10, 2023

Recall number

D-0914-2023

What should I do? Medicine recall: what to do

Source: FDA · Drug enforcement report, recall number D-0914-2023. The agency record governs; check it and the company before acting.