TOPIC: One Lot of Fentanyl Transdermal System, 25 mcg/hr by Alvogen: Recall - Due to a Defective Delivery System
AUDIENCE: Patient, Health Care Professional, Pharmacy, Pain Management
ISSUE: Alvogen is recalling one lot of Fentanyl Transdermal System, 25 mcg/hr transdermal patches because there is a potential that patches could be multi-stacked, adhered one on top of the other, in a single product pouch. This transdermal system is manufactured by Kindeva Drug Delivery L.P. and is distributed by Alvogen, Inc. as a private label distributor.
There is a possibility that the application of a multi-stacked 25 mcg/hr 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.
The affected Fentanyl Transdermal System lot is 108319 and it was distributed nationwide.
To date, Alvogen has received one serious adverse event related to this recall.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: The product is indicated for the management of severe and persistent pain in opioid-tolerant patients, that requires an extended treatment period with a daily opioid analgesic in opioid-tolerant patients, and for which alternative treatment options are inadequate.
RECOMMENDATIONS:
-
Patients 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.
-
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.
-
Pharmacies are requested not to dispense any product subject to this recall.
-
Alvogen, Inc. is notifying its distributors and direct customers by certified letter and is arranging for return and replacement of all recalled products.
-
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.
|
