Class I
Terminated
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.
- Company
- Alvogen, Inc
- Recall Initiated
- April 19, 2019
- Posted
- May 15, 2019
- Recall Number
- D-1277-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 119,608 cartons
- Firm Location
- Pine Brook, NJ, United States
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.
Distribution
Nationwide in the USA
Lot / Code Info
Lot#: 180060, Exp 05/2020; 180073, Exp 06/2020.
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