Defective Packaging Leads to Recall of Fentanyl Transdermal 25 mcg Patches

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On January 31, Alvogen, Inc, issued a voluntary, nationwide recall for one lot of Fentanyl Transdermal System 25 mcg/h patches. The patches are normally packaged with a single patch per pouch, but due to a defective delivery system, in the recalled lot there is a potential for the patches to be adhered together or multi-stacked. This creates a risk of a patient absorbing too high of a Fentanyl dose than what was intended, resulting in respiratory depression or death.

Recalled Fentanyl Patch Lot & Instructions for Patients

The affected Lot number of Fentanyl Transdermal System, 25 mcg/h is 108319 with an expiration date 04/2027. Patients with Fentanyl patches affected by the recall should immediately remove them and contact their healthcare prescriber. Additionally, they should return unused patches to the dispensing pharmacy.

Affected patients can reach out to the transdermal patch’s distributor, Alvogen, Inc., with specific questions about the recall via email (alvogensmb@continuumindia.com) or by calling 866-770-3024. 

What are Fentanyl transdermal patches used for?

Fentanyl is a potent opioid used for the management of severe or persistent pain in patients who have a tolerance for opioids and require extended daily use or in which alternative pain treatment options are not adequate.

This transdermal system is manufactured by Kindeva Drug Delivery L.P., Northridge, CA and is distributed by Alvogen, Inc. as a private label distributor.

MyMatrixx Response to Recall

MyMatrixx transaction records indicate that scripts for the Fentanyl Transdermal 25 mcg patches are low for our book of business. If you have any questions about this recall, please contact your MyMatrixx account team.