Drug product
Buprenorphine Transdermal System 5 mcg/hour, 4 transdermal systems/4 disposal units per carton, Rx Only, Manufactured by: 3M Drug Delivery Systems, 19901 Nordhoff street, Northridge, CA 91324 USA, Manufactured for: Teva Pharmaceuticals USA Inc., North Wales, PA 19454, carton NDC: 0093-3656-40, patch NDC: 0093-3656-21.
D-0003-2021
Product summary
- Event
- Event 86379
- Status
- Terminated
- Classification
- Class II
- Quantity
- 32,543 cartons
- Official record key
drug-enforcement:D-0003-2021
Official wording
Reason: Failed Stability Specifications: Below specification result for buprenorphine release rate.
Code information: Lot # 190017, exp. 02/2021; 190161, exp. 08/2021
Distribution pattern: Nationwide in the U.S. and PR
Derived failure modes
-
Potency or specification failure
Failed Stability Specifications