FDAFDA · Food and drugs·Recall number D-1693-2012
Fentanyl Transdermal System, 100 mcg/h, each transdermal system contains: 10 mg fentanyl and 0.4 mL alcohol USP, Rx only, supplied in single pouches (NDC 0591-3214-54 (pouch)), 5 pouches per carton (NDC 0591-3214-72 (Carton)), Manufactured by Watson laboratories Inc., Corona, CA, Distributed by: Watson, Pharma Inc.
Published October 3, 2012 · Recall initiated: July 11, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Subpotent; some patches may not contain fentanyl gel
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Actavis
- Distributor
- Nationwide
- Lot
- Lot number 455040A (carton) 455040 (pouch)
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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