Recalls / Class III
Class IIID-0540-2018
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.
- Affected lot / code info
- 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.
Why it was recalled
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1090 Horsham Rd, N/A, North Wales, Pennsylvania 19454-1505
Distribution
- Quantity
- 1,118,046 (5 pouches/carton)
- Distribution pattern
- Distributed nationwide within the United States
Timeline
- Recall initiated
- 2018-01-29
- FDA classified
- 2018-02-22
- Posted by FDA
- 2018-02-14
- Terminated
- 2018-09-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0540-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.