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.
Reason for recall: Failed Stability Specifications: Below specification result for buprenorphine release rate.
Recall initiated: 20200904
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated