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

FDA recall notice · announced February 14, 2018 · Teva Pharmaceuticals

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

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

Notes

Distribution: Distributed nationwide within the United States
Lot/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.
Quantity: 1,118,046 (5 pouches/carton)
Status: Terminated
Products in this recall event:
- 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, (D-0543-2018)
- Fentanyl Transdermal System, 50 mcg/h, packaged in 5 pouch system cartons (NDC 0591-3212-72), Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis P (D-0541-2018)
- 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, I (D-0542-2018)
- 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 P (D-0540-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.