Q: What is being recalled?

A: Actavis is conducting a voluntary recall at the wholesale/retail levels of 18 lots of its Fentanyl Transdermal System 25 mcg/hour strength. Consumers are encouraged to return any recalled product in their possession. The affected lots are:

Q: Why is it being recalled?

A: Actavis identified one lot of 25 mcg/hour Fentanyl patch (Control/Lot #30349) shipped to market that contained one patch that released in vitro (test tube) its active ingredient faster than the approved specification.

An accelerated release of Fentanyl from a 25 mcg/hour patch could lead to adverse events for at-risk patients, such as children and the elderly, including excessive sedation, respiratory depression, hypoventilation (slow breathing), and apnea (temporary suspension of breathing).

As a precautionary measure, in addition to the aforementioned lot, Actavis is recalling the 17 additional Control/Lot numbers due to the possibility that additional patches may release active ingredient faster than the approved specification.

Q: I am a pharmacist and I want to return my product. What do I need to do?

A: Please call 1-888-896-4562. We have operators available 24 hours a day/7 days per week to help you with the return and reimbursement process.

Q: I am a patient/consumer and I want to return my product. What do I need to do?

A: Please call 1-877-422-7452. We have operators available 24 hours a day/7 days per week to help you with the return and reimbursement process.

Q: Where is this product made?

A: It is made for Actavis by Corium International in Grand Rapids, Michigan.

Q: What is the potential risk for someone who uses a recalled patch?

A: An accelerated release of Fentanyl from a 25 mcg/hour patch may lead to adverse events for at-risk patients such as children and the elderly, including excessive sedation, respiratory depression, hypoventilation (slow breathing), and apnea (temporary suspension of breathing).

In laboratory testing, Actavis identified one lot of 25 mcg/hour Fentanyl patch (Control/Lot #30349) shipped to market that contained one patch that released in vitro (test tube) its active ingredient faster than the approved specification.

As a precautionary measure, in addition to the aforementioned lot, Actavis is recalling the 17 additional Control/Lot numbers due to the possibility that additional patches may release active ingredient faster than the approved specification.

Q: Who can I talk to if I have medical questions about a patch?

A: First and foremost, in case of a medical emergency seek medical attention and if needed, call 911.

To talk with a health professional about the Actavis Fentanyl Transdermal System product, please call 1-877-422-7452. This number will be answered 24 hours per day / 7 days a week.

Q: What is the problem with this medication?

A: Actavis identified one lot of 25 mcg/hour Fentanyl patch (Control/Lot #30349) shipped to market that contained one patch that released in vitro (test tube) its active ingredient faster than the approved specification.

An accelerated release of Fentanyl from a 25 mcg/hour patch may lead to adverse events for at-risk patients, such as children and the elderly, including excessive sedation, respiratory depression, hypoventilation (slow breathing), and apnea (temporary suspension of breathing).

Q: What exactly is this product? What are its basic ingredients and what does the product do?

A: Fentanyl is a potent "Schedule 2" opioid medication indicated for management of persistent moderate to severe chronic pain that requires continuous, around-the-clock opioid administration for an extended period of time, and cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate-release opioids.

To view a copy of the package insert listing the product ingredients please download:
Fentanyl_Transdermal_System_Rev_1009.pdf

We also have medical affairs professionals on standby to answer medical questions: 1-877-422-7452.