A generic fentanyl transdermal patch, with a release rate of 12mcg per hour, applied to the skin. (Photo by DanielTahar [CC BY-SA 4.0 ])
MARYLAND — The Food and Drug Administration (FDA) announced a voluntary recall of a small number of cartons labeled Fentanyl 12 mcg/h Transdermal System patches on April 19. Fentanyl is used to manage pain for patients who can tolerate opioids.
The recalled cartons contained 50 mcg/h patches instead of 12 mcg/h patches.
Using a 50 mcg/h patch instead of a prescribed 12 mcg/h patch could result in serious, life threatening or fatal respiratory depression. Groups at potential increased risk could include first time recipients of such patches, children, and the elderly. To date, Alvogen, Inc. hasn’t received any reports of adverse events related to this issue.
The affected Fentanyl Transdermal System lots include:
- Lot 180060 of Fentanyl Transdermal System, 12 mcg/h, expiration date 05/2020
- Lot 180073 of Fentanyl Transdermal System, 12 mcg/h, expiration date 06/2020
If anyone uses Fentanyl 12 mcg/h patches, check that the dosage on the packaging of the individual patches is correct and don’t take the wrong dosage. And if a person has a wrong dosage, contact the local pharmacy at the number on the prescription label.
The mislabeled product is packaged in a 12 mcg/h primary carton. These lots of Fentanyl Transdermal System were distributed Nationwide to the pharmacy level.
Alvogen Inc. is notifying its distributors and direct customers by certified letter and is arranging for return and replacement of all recalled products. Pharmacies are requested not to dispense any product subject to this recall. Patients that have product subject to this recall should immediately remove any patch currently in use and contact their health care provider. Patients with unused product should return it to point of purchase for replacement.
Questions regarding this recall should be directed to Alvogen Customer Complaints by calling 866-770-3024 or sending an e-mail to firstname.lastname@example.org from Monday to Friday from 9:00 am to 5:00 pm EST. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product.