April 07, 2021
Cardinal Health Inc. has initiated a voluntary recall of 48 boxes of Tremfya (guselkumab) injection, according to the April 7, 2021, US Food and Drug Administration (FDA) Enforcement Report. The report listed temperature abuse as the reason for the recall.
The recall affects Tremfya, 100 mg/mL, one single-dose prefilled syringe per carton (NDC 57894-640-01), coded KESOY.AI (Exp. 4/22). The product was manufactured by Janssen Biotech Inc., Horsham, PA, and distributed in Alabama, Louisiana, Mississippi, and Tennessee.
Cardinal Health Inc. initiated the recall March 9, 2021. On March 29, 2021, the FDA designated the recall Class III. Under the recall classification, use of the affected product is not likely to cause harm.
Tremfya is a prescription medication used to treat adults with moderate to severe plaque psoriasis and adults with active psoriatic arthritis.