Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg 30 tablets per bottle, Rx only, Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5720-56

Recall Number: D-0983-2017

Firm: Teva Pharmaceuticals USA

Classification: Class III

Status: Terminated

Report Date: 20170726

Initiation Date: 20170629

Termination Date: 20180426

Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.

Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg 30 tablets per bottle, Rx only, Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5720-56