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Safety Alert: Fentanyl
Recall of Two Lots of FENTANYL (also sold as DURAGESIC) 50 mcg/hr Transdermal System Patches
What does this mean?
This recall should be taken seriously since direct exposure to fentanyl gel can increase the amount of fentanyl absorbed by the skin, and potentially lead to life-threatening consequences such as difficulty breathing and low blood pressure. Patients may also experience increased drowsiness or impaired judgment.
If you are or someone you care for is using 50 mcg/hr Fentanyl Transdermal System patches or DURAGESIC (fentanyl transdermal system) Patches, check the box or foil pouch to find out who they were made by and what lot number is printed on the box or pouch. If your patches are made by PriCara, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc or Sandoz, Inc and the lot number printed on it matches the lot numbers in the recall, you can return them to your pharmacy to possibly exchange them, or you can contact the manufacturer directly at the following numbers:
DURAGESIC 50 mcg/hr patches being recalled: lot number 0817239. Anyone with 50 mcg/hr DURAGESIC patches from this lot may call 800-547-6446.
The Sandoz Inc. 50 mcg/hr patches being recalled: lot number 0816851. Anyone with 50 mcg/hr Sandoz Inc. patches from this lot may call 800-901-7236.
If you are not sure who has made your patch, or cannot find a lot number, please take your patches to your pharmacist for them to check as soon as possible. If you have medical questions or any other questions about the recall, you should contact your physician, pharmacist, or other health care provider.
PriCara, a Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., has voluntarily recalled lot number 0817239 of 50 microgram/hour (mcg/hr) DURAGESIC (fentanyl transdermal system) patches sold by PriCara and lot number 0816851 of 50 mcg/hr fentanyl patches sold by Sandoz Inc. Patches from these lot numbers may have a small cut on the patch which could leak fentanyl gel, possibly exposing patients or caregivers directly to the product. No other strengths or lots are affected by this recall.
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