Depression Medication Recalled

Lupin Pharmaceuticals Inc is recalling 1902 bottles of imipramine pamoate capsules following out-of-specification results from a dissolution test at the 9-month time point, according to the October 27, 2021, US Food and Drug Administration (FDA) Enforcement Report. 

The recall affects 125-mg imipramine pamoate capsules in 30-count bottles (NDC 68180-316-06) from lot H002205 (Exp. 8/23). The tablets were manufactured for Lupin Pharmaceuticals, Baltimore, MD, by Lupin Limited, Pithampur, India, and distributed throughout the United States. 

Lupin Pharmaceuticals voluntarily initiated the recall October 8, 2021. On October 22, 2021, the FDA designated the recall Class II, communicating use of the medication may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm. 

Imipramine pamoate is a prescription tricyclic antidepressant.