Alvogen has issued a nationwide recall of one lot of Fentanyl Transdermal System 25 patches because the patches may stick together, providing unhealthy – even fatal - dosages.
The company says there is a possibility that the application of a multi-stacked 25 mcg/h patch could result in serious, life-threatening, or fatal respiratory depression. Groups at potentially increased risk could include first-time recipients of such patches, children, and the elderly. So far, Alvogen has received one serious adverse event related to this recall.
The product is used for the management of severe and persistent pain in opioid-tolerant patients who require an extended treatment period with a daily opioid analgesic. The affected Fentanyl Transdermal System lot is:
Lot 108319 of Fentanyl Transdermal System, 25 mcg/h, expiration date 04/2027.
This lot of Fentanyl Transdermal System was distributed nationwide at the pharmacy and patient level.
What to do
Alvogen, Inc. is notifying its distributors and direct customers by certified letter and is arranging for the return and replacement of all recalled products. Pharmacies are requested not to dispense any product subject to this recall
Patients who have the product subject to this recall should immediately remove any patch currently in use and contact their healthcare provider. Patients with any unused product should return it to the point of purchase for replacement. 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.
Questions regarding this recall should be directed to Alvogen Customer Complaints by calling 866-770-3024 or sending an e-mail to alvogensmb@continuumindia.com, Monday to Friday from 9:00 am to 5:00 pm EST.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Email Mark Huffman at mhuffman@consumeraffairs.com