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.
Reported: May 15, 2019 Initiated: April 19, 2019 #D-1277-2019
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.
Details
- Recalling Firm
- Alvogen, Inc
- Units Affected
- 119,608 cartons
- Distribution
- Nationwide in the USA
- Location
- Pine Brook, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Alvogen, Inc. Units affected: 119,608 cartons.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 15, 2019. Severity: Critical. Recall number: D-1277-2019.
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