Reported Feb 14, 2018 · Terminated
Fentanyl Transdermal System, 100 mcg/h, packaged in 5 pouch system (NDC 0591-3214-72), Rx Only, Manufactured by:…
Teva Pharmaceuticals USA
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Teva Pharmaceuticals USA · 1090 Horsham Rd · North Wales, PA · 19454-1505
Is this the product you have?
- Fentanyl Transdermal System, 100 mcg/h, packaged in 5 pouch system (NDC 0591-3214-72), Rx Only
- Manufactured byActavis Laboratoies UT, Inc. Salt Lake City, UT 84108
- Distributed byActavis Pharma, Inc. Parsippany, NJ 07054 USA. Individual pouch NDC 0591-3214-54
- Lot codes and dates
Lot #: 1096857AExp. Feb 20181115872AExp. Apr 20181123625AExp. May 20181148775A. 1157255AExp. Aug 20181169928AExp. Nov 20181196300AExp. Apr 20191213533AExp. Jun 2019
- Amount recalled
- 554, 562 (5 pouches/carton)
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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