BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 8 mg, 30-count bottles, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-5379-56, UPC 3 0093-5379-56 2.

Recall Number: D-1325-2014

Firm: Teva Pharmaceuticals USA

Classification: Class II

Status: Terminated

Report Date: 20140528

Initiation Date: 20140407

Termination Date: 20141120

Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing.

BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 8 mg, 30-count bottles, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-5379-56, UPC 3 0093-5379-56 2.