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.
FDA recall notice · announced May 28, 2014 · Teva Pharmaceuticals
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The 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.
Notes
Distribution: Nationwide and Puerto Rico
Lot/code information: 34009367B, 34009368B, 34009369A, 34009370B, Exp 04/14; 34013141A, 34013142A, Exp 11/14; 34016682A, 34016683A, 34016684A, 34017000A, 34017001A, Exp 08/15
Quantity: 53,452 bottles
Status: Terminated
Products in this recall event:
- 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. (D-1324-2014)
- 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. (D-1325-2014)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.