Drug 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.
D-1325-2014
Product summary
- Event
- Event 68069
- Status
- Terminated
- Classification
- Class II
- Quantity
- 53,452 bottles
- Official record key
drug-enforcement:D-1325-2014
Official wording
Reason: Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing.
Code information: 34009367B, 34009368B, 34009369A, 34009370B, Exp 04/14; 34013141A, 34013142A, Exp 11/14; 34016682A, 34016683A, 34016684A, 34017000A, 34017001A, Exp 08/15
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
out of specification