December 03, 2020
Jubilant Cadista Pharmaceuticals Inc. is recalling 4416 bottles of clomipramine, citing failure of capsules to meet specifications. The recall was included in the December 2, 2020, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects 30-count bottles of clomipramine hydrochloride capsules, 50 mg (NDC 59746-711-30), from lot 20P0141 (Exp. 2/22). The bottles were distributed throughout the United States.
Jubilant Cadista Pharmaceuticals voluntarily initiated the recall November 6, 2020. The FDA designated the recall Class II on November 24, 2020, signaling that use of the medication could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.
Clomipramine is a prescription antidepressant used to treat people with obsessive-compulsive disorder.