Teva Pharmaceuticals USA recalls BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 8 mg, 30-count bottles, Rx only, Teva Pharmaceuticals USA, Sellersville,
Recalled May 28, 2014 · FDA recall D-1325-2014 · Teva Pharmaceuticals USA
Hazard
Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing. · FDA Class II
Units
53,452 bottles
Sold at
Nationwide and Puerto Rico
Description
Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing.
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.
Manufacturer(s)
Teva Pharmaceuticals USA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →