drugs Class II Updated 2014-05-28

Teva Pharmaceuticals USA recalls BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 8 mg, 30-cou

Recalled 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.


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 34009367B, 34009368B, 34009369A, 34009370B, Exp 04/14; 34013141A, 34013142A, Exp 11/14; 34016682A, 34016683A, 34016684A, 34017000A, 34017001A, Exp 08/15
View official government recall

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