October 08, 2020
Teva Pharmaceuticals USA is recalling two lots of buprenorphine patches because samples tested below specification for the drug’s rate of release, according to the October 7, 2020, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects 32,543 cartons of buprenorphine transdermal systems, 5 mcg/hour, four transdermal systems per carton (patch NDC 0093-3656-21, carton NDC 0093-3656-40), from lots 190017 (Exp. 2/21) and 190161 (Exp. 8/21). The product was manufactured by 3M Drug Delivery Systems for Teva Pharmaceuticals and distributed in the United States and Puerto Rico.
Teva Pharmaceuticals voluntarily initiated the recall September 4, 2020. On October 1, 2020, the FDA designated the recall Class II. Products affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm exists.
Buprenorphine is a narcotic analgesic available with a prescription to relieve severe ongoing pain.