D-0540-2018 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- February 14, 2018
- Initiation Date
- January 29, 2018
- Termination Date
- September 5, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,118,046 (5 pouches/carton)
Product Description
Fentanyl Transdermal System. 25 mcg/h, packaged in 5 pouch system cartons (NDC 0591-3198-72), 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 0591-3198-54.
Reason for Recall
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Distribution Pattern
Distributed nationwide within the United States
Code Information
Lot #:1103907A, Exp. Mar 2018; 1114170A, Exp. Apr 2018; 1117212A,, Exp. May 2018; 1130863A, 1140570A, Exp. Jul 2018; 1153178A, Exp. Aug 2018; 1153185A, Exp. Sep 2018; 1171608A, Exp. Nov 2018; 1188715A, Exp. Jan 2019; 1193264A, 1208789A, Exp. Apr 2019; 1212340A, 1225166A, Exp. Jul 2019; 1238442A, Exp. Aug 2019.