Drug product
Fentanyl Transdermal System. 75 mcg/h, packaged in 5 pouch system (NDC 0591-3213-72), Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA. Individual pouch NDC 0591-3213-54.
D-0542-2018
Product summary
- Event
- Event 79062
- Status
- Terminated
- Classification
- Class III
- Quantity
- 576, 760 (5 pouches/carton)
- Official record key
drug-enforcement:D-0542-2018
Official wording
Reason: Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Code information: Lot #: 1107745A, Exp. Mar 2018;1122452A, 1137109A, Exp. Jun 2018; 1144515A, Exp. Oct 2018; 1189477A, Exp. Mar 2019; 1215224A, Exp. Aug 2019.
Distribution pattern: Distributed nationwide within the United States
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications