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.
Reported: February 14, 2018 Initiated: January 29, 2018 #D-0543-2018
Product Description
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.
Reason for Recall
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Details
- Recalling Firm
- Teva Pharmaceuticals USA
- Units Affected
- 554, 562 (5 pouches/carton)
- Distribution
- Distributed nationwide within the United States
- Location
- North Wales, PA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Teva Pharmaceuticals USA. Units affected: 554, 562 (5 pouches/carton).
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 14, 2018. Severity: Low. Recall number: D-0543-2018.
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