Safety Alerts & Recalls

What does this mean?

Actavis is now asking consumers to return any recalled fentanyl product they have in their possession. If you or someone you care for uses Fentanyl Transdermal System 25 mcg/h patches, please check your supply to see if it is involved in the recall. Consumers with Actavis brand Fentanyl 25 mcg/h patches may call 1-877-422-7452 (24 hours/day, 7 days/week) for return instructions and information.

If you have any concerns about fentanyl, especially the recalled Actavis brand Fentanyl 25 mcg/h patches, you can also speak to your doctor or pharmacist. If you or someone you care for is experiencing difficulty breathing, low blood pressure, unexplained drowsiness, impaired judgment, or other concerning symptoms from fentanyl, please seek medical attention immediately.

Actavis Issues Consumer Update to Recall of Fentanyl Transdermal System 25 mcg/h Patches

In a follow up to the October 21, 2010 recall of 18 lots of Fentanyl Transdermal System 25 mcg/h C-II patches, Actavis is encouraging consumers to return any recalled product in their possession. Actavis Inc. issued this recall because of a report of one lot of Fentanyl Transdermal System 25 mcg/h patches with one patch that released its active ingredient faster than the approved rate of release of medication. A faster release of fentanyl from a patch can lead to adverse events for at-risk patients, including excessive drowsiness, impaired judgment, slow breathing, temporary stopping of breathing, and low blood pressure. Actavis is recalling several other lot numbers as a precaution because of the possibility that additional patches may have the same problem.

The following lot numbers of Fentanyl Transdermal System 25 mcg/h patches have been recalled: 30041, 30049, 30066, 30096, 30097, 30123, 30241, 30256, 30257, 30258, 30349, 30350, 30391, 30392, 30429, 30430, 30431, and 30517.

The lot number appears on the bottom of the product box and on the black and white side of each individual patch packaging, in the lower left corner.

For more information, please visit: more information here

Source: Manufacturer
Publication Date: 2010-11-04
Last Updated: 2010-11-04

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