Eighteen lots of Fentanyl transdermal patches distributed in the United States have been recalled by Actavis, Inc.
The 25 mcg/hour patches may have a fold-over defect that allows active drug to be released faster than intended. In one lot of the recalled patches, one patch was found leaking gel. The remaining lots are being voluntarily recalled as a precaution.
Fentanyl is a strong opioid. The patch releases a measured amount of the drug each hour which is absorbed by skin. Damaged patches may release too much medicine, potentially causing slowed or stopped breathing that can lead to death.
Caregivers who handle damaged patches and get gel on their own skin are also at risk.
The patches are packed individually in boxes of five.
Actavis warns patients and their caretakers:
Anyone who comes in contact with fentanyl gel should thoroughly rinse exposed skin with large amounts of water only; do not use soap. Immediately dispose of affected patches that may be damaged or compromised in any way by flushing them down the toilet, using caution not to handle them directly. Damaged and/or compromised patches that have leaked gel will not provide effective pain relief.
Actavis has operators available to help customers, health professionals and consumers 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)
You can find the control/lot numbers of the recalled patches on the bottom of the product box and on the black and white side of each individual patch packaging, in the lower left corner. Control/lot numbers and expiration dates are:
| 30041, Exp 12/2011 | 30258, Exp 03/2012 |
| 30049, Exp 12/2011 | 30349, Exp 03/2012 |
| 30066, Exp 12/2011 | 30350, Exp 03/2012 |
| 30096, Exp 01/2012 | 30391, Exp 03/2012 |
| 30097, Exp 02/2012 | 30392, Exp 04/2012 |
| 30123, Exp 01/2012 | 30429, Exp 04/2012 |
| 30241, Exp 02/2012 | 30430, Exp 04/2012 |
| 30256, Exp 02/2012 | 30431, Exp 04/2012 |
| 30257, Exp 03/2012 | 30517, Exp 04/2012 |
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