On October 21, 2010, Actavis announced a recall of 18 Control/Lots of Fentanyl Transdermal System 25 mcg/h. Under this recall, all wholesalers and retailers are being asked to return the product they have on hand or in stock. Consumers are encouraged to return product in their possession. Fentanyl patches sold by Actavis in Europe are not impacted in this recall.
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 Control/Lot Numbers listed below due to the possibility that additional patches may release active ingredient faster than the approved specification.
Click here to see if your Fentanyl 25 mcg/h is affected by the recall.
The 18 Control/Lots included in this recall are:
Fentanyl Transdermal System 25mcg/hr CII
NDC # 67767-120-18
Control/Lot # 30041 Expiration 12/2011
Control/Lot # 30049 Expiration 12/2011
Control/Lot # 30066 Expiration 12/2011
Control/Lot # 30096 Expiration 01/2012
Control/Lot # 30097 Expiration 02/2012
Control/Lot # 30123 Expiration 01/2012
Control/Lot # 30241 Expiration 02/2012
Control/Lot # 30256 Expiration 02/2012
Control/Lot # 30257 Expiration 03/2012
Control/Lot # 30258 Expiration 03/2012
Control/Lot # 30349 Expiration 03/2012
Control/Lot # 30350 Expiration 03/2012
Control/Lot # 30391 Expiration 03/2012
Control/Lot # 30392 Expiration 04/2012
Control/Lot # 30429 Expiration 04/2012
Control/Lot # 30430 Expiration 04/2012
Control/Lot # 30431 Expiration 04/2012
Control/Lot # 30517 Expiration 04/2012
Actavis distributed the subject lot numbers from 04/13/2010 to 09/09/2010.
Lot/Control numbers can be found in the area indicated by the circled area on the product box pictured below. This number is also on the black and white side of the individual patch packaging in the lower left corner.
Actavis has operators available to help consumers, customers and health professionals with the following information:
Medical Issue/Adverse Event/Product Questions
1-877-422-7452 (24 hours/day, 7 days/week)
Return/Reimbursement Questions
1-888-896-4562 (24 hours/day, 7 days/week)
Consumers may also send an email to fentanyl.recall@gencopharma.com for assistance with a recalled product form.
We have notified the FDA of our action.
Information for Patients/Consumers
This is a recall of 18 lots of the 25 mcg/hour Fentanyl Transdermal System. While not being recalled at the consumer level, you are encouraged to return any patch you may have from any of the recalled lots. Please call 1-888-896-4562 (24 hours/day, 7 days/week) for return information.
In the event of any medical emergency, patients should call 911. Otherwise, please refer to the numbers listed above. We have operators on standby to assist you.
Information for Actavis Wholesale and Retail Customers
Please contact 1-888-896-4562 for information regarding refunds and return of product.
Information for Health Professionals
Health professionals with medical questions, adverse event or product questions regarding the recalled Fentanyl product can call 1-877-422-7452.
Health professionals with questions regarding how to return recalled products and how to receive reimbursement can call 1-888-896-4562.
Fentanyl is a Schedule 2 opioid, which is a controlled substance.
You may also find helpful information in the Frequently Asked Questions.