Drug recall D-1277-2019
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.
Reason for recall
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.
Lots and codes
Lot#: 180060, Exp 05/2020; 180073, Exp 06/2020.
Recall details
- Recalling firm
- Alvogen, Inc, Pine Brook, NJ
- Quantity
- 119,608 cartons
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- April 19, 2019
- Terminated
- August 14, 2019
Related products
- Fentanyl system – drug information
- NDC 47781-424 Fentanyl system · Fentanyl 25 ug/1 · ALVOGEN
- NDC 47781-426 Fentanyl system · Fentanyl 50 ug/1 · ALVOGEN
- NDC 47781-428 Fentanyl system · Fentanyl 100 ug/1 · ALVOGEN
- NDC 47781-427 Fentanyl system · Fentanyl 75 ug/1 · ALVOGEN
- NDC 47781-423 Fentanyl system · Fentanyl 12.5 ug/1 · ALVOGEN