Teva Pharmaceuticals USA recalls Buprenorphine Transdermal System 5 mcg/hour, 4 transdermal systems/4 disposal units per carton, Rx Only, Manufactured by
Recalled October 7, 2020 · FDA recall D-0003-2021 · Teva Pharmaceuticals USA
Hazard
Failed Stability Specifications: Below specification result for buprenorphine release rate. · FDA Class II
Units
32,543 cartons
Sold at
Nationwide in the U.S. and PR
Description
Failed Stability Specifications: Below specification result for buprenorphine release rate.
Product
Buprenorphine Transdermal System 5 mcg/hour, 4 transdermal systems/4 disposal units per carton, Rx Only, Manufactured by: 3M Drug Delivery Systems, 19901 Nordhoff street, Northridge, CA 91324 USA, Manufactured for: Teva Pharmaceuticals USA Inc., North Wales, PA 19454, carton NDC: 0093-3656-40, patch NDC: 0093-3656-21.
Manufacturer(s)
Teva Pharmaceuticals USA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →