Drug product
Buprenorphine Transdermal System, CIII 10 mcg/hour, 4 Transdermal Systems One package of 4 disposal units, Rx Only, Manufactured by: Aveva Drug Delivery Systems Inc. Miramar, FL. 33025, Manufactured for: Apotex Corp Weston, FL. 33326, NDC 60505-7077-05
D-0465-2023
Product summary
- Event
- Event 91712
- Status
- Terminated
- Classification
- Class III
- Quantity
- 11,520 cartons
- Official record key
drug-enforcement:D-0465-2023
Official wording
Reason: Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint.
Code information: Lot#: 51835 Exp: 06/2023
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Out of specification