Recall: D-0003-2021

Class II - Potentially Harmful

Class IIClassification

2020-09-04Initiated

TerminatedStatus

Teva Pharmaceuticals USAFirm

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

Failed Stability Specifications: Below specification result for buprenorphine release rate.

Distribution

Nationwide in the U.S. and PR

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.