Drug product
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.
D-1277-2019
Product summary
- Firm
- Alvogen, Inc
- Event
- Event 82669
- Status
- Terminated
- Classification
- Class I
- Quantity
- 119,608 cartons
- Official record key
drug-enforcement:D-1277-2019
Official wording
Reason: 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.
Code information: Lot#: 180060, Exp 05/2020; 180073, Exp 06/2020.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Unknown
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.