BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 2 mg, 30-count bottles, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-5378-56, UPC 3 0093-5378-56 5.
Recall Number: D-1324-2014
Firm: Teva Pharmaceuticals USA
Classification: Class II
Status: Terminated
Report Date: 20140528
Initiation Date: 20140407
Termination Date: 20141120
Reason for Recall
Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing.
Product Description
BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 2 mg, 30-count bottles, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-5378-56, UPC 3 0093-5378-56 5.