FDA-Drug2014-05-28Class II
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.
Teva Pharmaceuticals USA
Hazard
Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing.
Sold states
Nationwide and Puerto Rico
Affected count
53,452 bottles
Manufactured in
1090 Horsham Rd, N/A, North Wales, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1325-2014Don't want to check this manually?
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