D-0542-2018 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
- 576, 760 (5 pouches/carton)
Product Description
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.
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 #: 1107745A, Exp. Mar 2018;1122452A, 1137109A, Exp. Jun 2018; 1144515A, Exp. Oct 2018; 1189477A, Exp. Mar 2019; 1215224A, Exp. Aug 2019.