Drug product
Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg 30 tablets per bottle, Rx only, Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5720-56
D-0983-2017
Product summary
- Event
- Event 77725
- Status
- Terminated
- Classification
- Class III
- Quantity
- 25264 bottles
- Official record key
drug-enforcement:D-0983-2017
Official wording
Reason: Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.
Code information: Lot #: 30227613A, 30227614A, 30227615A, EXP 6/2017; 30228559A, 30228560A, EXP 9/2017; 3000123, EXP 7/2018
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
out of specification