Reported May 15, 2019 · Terminated
FENTANYL Transdermal System, 12 mcg/h, five (12 mcg/h) systems per carton, Rx only, Distributed by: Alvogen, Inc., Pine…
Alvogen, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.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: Alvogen, Inc · 10 Bloomfield Ave Bldg B Ste 2 · Pine Brook, NJ · 07058-9743
Is this the product you have?
- FENTANYL Transdermal System, 12 mcg/h, five (12 mcg/h) systems per carton, Rx only
- Distributed byAlvogen, Inc., Pine Brook, NJ 07058
- Manufactured by
3M Drug Delivery SystemsSt. PaulMN 55107NDC 47781-423-47
- Lot codes and dates
Lot#: 180060Exp 05/2020180073Exp 06/2020
- Amount recalled
- 119,608 cartons
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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