September 27, 2018
Torrent Pharma Inc. is recalling 30-count bottles of lamotrigine extended-release tablets, USP, 200 mg (NDC 13668-342-30), after the drug failed to meet dissolution specifications during testing, according to the September 26, 2018, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects 15,384 bottles from lot BFR5D002 (Exp. 11/19) that were distributed nationwide.
Torrent Pharma initiated the voluntary recall September 11, 2018. On September 20, 2018, the FDA designated the recall Class II, communicating use of the drug may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.
Available with a prescription, lamotrigine extended-release tablets are used to treat epilepsy and bipolar disorder.
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