Anticonvulsant Recalled

Torrent Pharma Inc is recalling 15,336 bottles of 200-mg carbamazepine tablets because samples failed to meet dissolution specifications during testing, according to the January 19, 2022, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects 100-count bottles of carbamazepine tablets (NDC 13668-268-01) from batch 4J11G002 (Exp. 8/24). The tablets were manufactured by Torrent Pharmaceuticals Ltd, Bharuch, India, for Torrent Pharma Inc, Basking Ridge, NJ, and distributed throughout the United States.

Torrent Pharma voluntarily initiated the recall December 2, 2021. The FDA designated the recall Class II on January 11, 2022, signaling use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

Carbamazepine is an anticonvulsant available with a prescription for the treatment of seizures and pain associated with neuralgia.