FDAFDA · Food and drugs·Recall number D-1277-2019
FENTANYL Transdermal System, 12 mcg/h, five (12 mcg/h) systems per carton, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058; Manufactured by: 3M Drug Delivery Systems, St. Paul, MN 55107, NDC 47781-423-47.
Published May 15, 2019 · Recall initiated: April 19, 2019
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
Product Mix-Up: Customer complaint that their carton labeled as Fentanyl Transdermal Systems, 12 mcg/h contained five patches labeled and containing 50 mcg/h.
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Brand
- FENTANYL SYSTEM
- Manufacturer
- Alvogen, Inc
- Distributor
- Nationwide in the USA
- Lot
- Lot#: 180060, Exp 05/2020; 180073, Exp 06/2020.
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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