FDA recall D-0914-2023

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 for recall

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

Distribution

Distributed nationwide in the USA.

Key facts

Status

Terminated

Initiation date

2023-07-10

Report date

2023-07-19

Termination date

2023-12-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0914-2023