Drug product
Fentanyl Transdermal System, 100 mcg/h, packaged in 5 pouch system (NDC 0591-3214-72), 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 0591-3214-54.
D-0543-2018
Product summary
- Event
- Event 79062
- Status
- Terminated
- Classification
- Class III
- Quantity
- 554, 562 (5 pouches/carton)
- Official record key
drug-enforcement:D-0543-2018
Official wording
Reason: Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Code information: Lot #: 1096857A, Exp. Feb 2018; 1115872A, Exp. Apr 2018; 1123625A, Exp. May 2018; 1148775A. 1157255A, Exp. Aug 2018; 1169928A, Exp. Nov 2018; 1196300A, Exp. Apr 2019; 1213533A, Exp. Jun 2019.
Distribution pattern: Distributed nationwide within the United States
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications