Recalls / Class III
Class IIID-0543-2018
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.
- Affected lot / code info
- 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.
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
- 554, 562 (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-0543-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.