Drug product
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
Product summary
- Event
- Event 68069
- Status
- Terminated
- Classification
- Class II
- Quantity
- 17,181 bottles
- Official record key
drug-enforcement:D-1324-2014
Official wording
Reason: Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing.
Code information: Lot #: 34013132A, 34013133A, 34013134A, 34013135A, 34013136A, Exp 11/14
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
out of specification