Safety Alerts & Recalls

What does this mean?

This recall for Duragesic 25 mcg/h (Fentanyl Transdermal System) was issued at a warehouse and pharmacy level only. The FDA and the manufacturer have determined that any recalled product that may have been dispensed to patients does not pose a significant health risk. However, you may wish to check your prescription and see if you have any Duragesic 25 mcg/h (Fentanyl Transdermal System) from lot 1103836P1. The lot number can be found on the outer packaging of the patch. If you have patches from this lot that have white spots on the patch or if you are concerned about using recalled patches, please take your prescription to your pharmacist to examine and possibly exchange.

If you have any concerns about your medicines or think you are experiencing side effects, you should speak to your doctor.

Ortho-McNeil-Janssen Pharmaceuticals, Inc. Recalls Single Lot of Duragesic 25 mcg/h

Ortho-McNeil-Janssen Pharmaceuticals, Inc. has recalled a single lot of Duragesic 25 mcg/h (Fentanyl Transdermal System). Lot number 1103836P1 has been recalled because the patches in this lot were found to have white spots caused by crystallization of the active ingredient fentanyl.

Duragesic contains the active ingredient fentanyl and is commonly used in the treatment of pain. This recall alert only applies to the single lot of Duragesic 25 mcg/h (Fentanyl Transdermal System). No other Fentanyl products were involved in this recall.

To view the FDA notice about this recall, please visit: more information here


more information here

Source: FDA
Publication Date: 2012-07-20
Last Updated: 2012-07-20

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