Medications & Supplements/Prescription Drugs

Alvogen, Inc: Fentanyl Transdermal Systems Recalled for Product Mix-Up and Overdose Risk

Agency Publication Date: May 3, 2019

Summary

Alvogen, Inc. is recalling 119,608 cartons of Fentanyl Transdermal System (fentanyl) patches because of a product mix-up. Cartons labeled as 12 mcg/h may actually contain five patches that are labeled and contain a much higher dose of 50 mcg/h. This error was discovered following a customer complaint and affects two specific lots distributed nationwide.

Risk

Using a 50 mcg/h patch when a 12 mcg/h dose is prescribed can lead to accidental respiratory depression (extremely slow breathing) and a potentially fatal overdose. This risk is especially critical for 'opioid-naive' patients who have not developed a tolerance to high-dose narcotics.

What You Should Do

Immediately check your Fentanyl Transdermal System carton for NDC 47781-423-47 and the following lot numbers and expiration dates: Lot 180060 (Exp 05/2020) or Lot 180073 (Exp 06/2020).
If your carton matches these lot numbers, open it and inspect the individual patches to see if they are labeled as 50 mcg/h instead of the prescribed 12 mcg/h.
If you find a mislabeled or higher-dose patch, do not use it; contact your healthcare provider or pharmacist immediately for guidance on obtaining a correct replacement and to discuss your treatment.
Return any unused, affected product to the pharmacy where you purchased it for a refund.
Contact Alvogen, Inc. at 1-888-723-3332 for further instructions or to report any issues with the product.
For additional questions or to report a related health issue, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: FENTANYL Transdermal System, 12 mcg/h (five systems per carton)

Model:

NDC 47781-423-47

Recall #: D-1277-2019

Lot Numbers:

180060 (Exp 05/2020)

180073 (Exp 06/2020)

Date Ranges: Expiration 05/2020, Expiration 06/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82669

Status: Resolved

Manufacturer: Alvogen, Inc

Sold By: pharmacies

Manufactured In: United States

Units Affected: 119,608 cartons

Distributed To: Nationwide

Agency Last Updated: May 13, 2019

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Immediately check your Fentanyl Transdermal System carton for NDC 47781-423-47 and the following lot numbers and expiration dates: Lot 180060 (Exp 05/2020) or Lot 180073 (Exp 06/2020).

If your carton matches these lot numbers, open it and inspect the individual patches to see if they are labeled as 50 mcg/h instead of the prescribed 12 mcg/h.

If you find a mislabeled or higher-dose patch, do not use it; contact your healthcare provider or pharmacist immediately for guidance on obtaining a correct replacement and to discuss your treatment.

Return any unused, affected product to the pharmacy where you purchased it for a refund.

Contact Alvogen, Inc. at 1-888-723-3332 for further instructions or to report any issues with the product.

For additional questions or to report a related health issue, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.