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.
Drug Recall
Official source record
- Recall number
- D-1277-2019
- Event ID
- 82669
- Classification
- Class I
- Status
- Terminated
- Recalling company
- Alvogen, Inc
- 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.
- Report date
- May 15, 2019
- Recall initiation date
- April 19, 2019
- Termination date
- August 14, 2019
- Distribution pattern
- Nationwide in the USA
Drug product identifiers
- Manufacturer
- ALVOGEN
- Brand name
- FENTANYL SYSTEM
- Generic name
- FENTANYL
- Substance name
- FENTANYL
- Product NDCs
- 47781-423; 47781-424; 47781-426; 47781-427; 47781-428
- Package NDCs
- 47781-423-11; 47781-423-47; 47781-424-11; 47781-424-47; 47781-426-11; 47781-426-47; 47781-427-11; 47781-427-47; 47781-428-11; 47781-428-47
- Route
- TRANSDERMAL
Where this information comes from
View FDA enforcement record -- the specific openFDA drug enforcement record this summary was built from.
This record comes from FDA's Enforcement Report database. Not every Enforcement Report record has a separate FDA.gov recall-announcement page.
FDA Enforcement Reports -- FDA's general, official recall and enforcement information.
Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for details.
Retrieved by Public Health Trace:
Frequently asked questions
What does a Class I mean?
A situation in which there is a reasonable probability that use of or exposure to a product will cause serious adverse health consequences or death.
Is this recall still active?
According to the FDA, this recall's status is "Terminated." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.
What should I do if I have this medication?
Do not start, stop, or change any medication based on this page. Follow the instructions published by the FDA and the recalling company (see the source links below), and talk to your pharmacist or physician if you have questions about a specific medication.
Where can I find more official information?
The source links below, published by the FDA, are the authoritative record for this recall, including any updates issued after this summary was retrieved.
Official guidance and record verification
Public Health Trace does not provide medical advice. The information below explains how to interpret this record and links to relevant official government sources. Review the linked official source for the current, authoritative information.
How to interpret this historical record
This record is preserved as published by FDA, as of August 14, 2019.
Status as reported: Terminated.
This page does not imply a current danger or a current consumer instruction -- review the official source for the most current information.
Public Health Trace republishes official FDA drug recall information -- it is not affiliated with the FDA, does not verify or supplement what the source has published, and does not provide medical advice. Never start, stop, or change a medication based on this page. Always follow the guidance of your pharmacist or physician, and consult the official source links above for the most current information. Read the full medical disclaimer.