November 16, 2018
An instruction mix-up has caused Janssen Pharmaceuticals Inc. to recall 1777 cartons of Ortho-Novum 1/35 (norethindrone/ethinyl estradiol) tablets, 1 mg/0.035 mg, 28-day regimen per pouch (NDC 50458-176-28), 6 Veridate Tablet Dispensers and 6 refills per carton (NDC 50458-176-06), according to the November 14, 2018, US Food and Drug Administration (FDA) Enforcement Report.
“Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser,” the FDA reported.
The recalled tablets, from lot 18BM114 (Exp. 3/20), were distributed across the United States.
Janssen Pharmaceuticals voluntarily initiated the recall October 23, 2018. The FDA designated it Class II November 6, 2018. The designation signals use of the affected products could cause temporary or medically reversible adverse health effects, or a remote possibility of serious harm.
Ortho-Novum 1/35 is a prescription combination hormone medication used to prevent pregnancy.
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