Product: 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.
Reason for recall: Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing.
Recall initiated: 20140407
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated