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There appears to be an ongoing problem with the manufacturing of pain patches.
Feb. 2004--Janssen Pharmaceutica recalled one lot of Duragesic (fentanyl transdermal system CII) 75 mcg per hour pain patch due to a potential leak in the product seal in a small percentage of pain patches (a few hundred thousand) for one control number, 0327192. Only this dosage strength and control number was affected (as of that date according to Janssen).
Other recommendations in the Feb. 2004 recall were said to include: Skin exposure to any leaked medication from a Duragesic patch may cause nausea, sedation, drowsiness, or potentially life-threatening complications.
Patients or caregivers in possession of Duragesic 75 mcg per hour patches, control number 0327192, must immediately contact their physician or pharmacist for specific instructions about returning affected patches and obtaining a new supply of medication.
Sudden discontinuation of Duragesic can cause health problems.
As of Feb. 2004 Janssen was not aware of any other dosage strengths or lot numbers that were affected. The pain patch wearing public and the healthcare profession was duly advised:
"Patients wearing Duragesic patches that are not from the affected lot can continue to wear them with confidence."
But only two months later...
UPDATE: April 2004--Janssen expanded its U.S. recall to include five manufacturing lots of Duragesic 75 mcg/hr pain patches with the control numbers of:
Only two months later, 2 million patches were now being recalled.
What happened to the confidence recommendation?
Over a year later in July 2005, the FDA issued a Public Health Advisory regarding the safe use of transdermal fentanyl patches in response to reports of numerous deaths in patients using opioid narcotic medication patches for pain management.
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