D-1277-2019 Class I Terminated
FDA drug recall D-1277-2019 was initiated by Alvogen, Inc on April 19, 2019 and is designated Class I. 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. The recall status is terminated (terminated August 14, 2019). Affected quantity: 119,608 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- May 15, 2019
- Initiation Date
- April 19, 2019
- Termination Date
- August 14, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 119,608 cartons
Product Description
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lot#: 180060, Exp 05/2020; 180073, Exp 06/2020.