Fentanyl Transdermal System Recall: Labeling Error
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.
What is the FDA recall status?
The FDA record lists this recall as terminated. This does not establish that a retained recalled product is safe to consume or use. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions.
Why was Fentanyl Transdermal System 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.
What should I do if I have this product?
Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.
Full 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.
Which lot codes, UPCs or models are affected?
Lot#: 180060, Exp 05/2020; 180073, Exp 06/2020.
- Agency record number
- 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.
- Recalling firm
- Alvogen, Inc
- Quantity
- 119,608 cartons
- Distribution
- Nationwide in the USA
- Recall started
- April 19, 2019
- Report date
- May 15, 2019
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (drug)