FDA 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.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2019-04-19

Report date

2019-05-15

Termination date

2019-08-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pine Brook, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1277-2019