FDA Recalls Fentanyl Patches Due To Dosing Errors

FDA Recalls Fentanyl Patches Due To Dosing Errors

Introduction

On April 21, the FDA announced a recall for an Alvogen Fentanyl Transdermal System over mislabeling issues in some cartons. The agency indicated that some cartons labeled as having 12 mcg/h patched were actually containing 50 mcg/h patches.

Though Alvogen Inc. had not received any adverse event reports related to the recall, such misinformation could pose serious risks for individuals who were prescribed the lower dose. The patches indicated 50 mcg/h reading; however, if a patient purchased the 12 mcg/h carton and used the 50 mcg/h patch carried init, this could lead to serious and fatal respiratory depression. The company said that the first time users, children, and the elderly would be at risk because of this mislabeling. The recall affects Lot 180060 of Fentanyl Transdermal System 12 mcg/h, expiration date 05/2020; and Lot 180073 of Fentanyl 12 mcg/h, expiration date 06/2020. Alvogen has notified distributors and customers about the recall through a certified letter and made arrangements for the return and replacement of all recalled products. The company has also requested pharmacies to stop dispensing products from the recalled lots. Patients who discovered the carton with the wrong dosage must inform their doctors and replace any unused pain patches from the point of purchase. Any adverse effects linked to the recalled products must be reported to the FDA’s MedWatch Adverse Event Reporting System.

Fentanyl pain patches are powerful medications prescribed to reduce the pain by gradually releasing fentanyl, which gets absorbed through the skin. It is 50 to100 times more powerful than morphine and has been linked to more than half of all opioid overdose deaths recorded in recent years, making it the most dangerous drug in the U.S.