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The U.S. Food and Drug Administration (FDA) recalled a medicated skin pain patch called Fentanyl because some batches of the product have been found to be released at a higher than prescribed rate. The Fentanyl Transdermal System recall was issued Oct. 21, 2010. It includes 18 lots of Fentanyl Transdermal System 25 mcg/h.

Fentanyl is a narcotic medication that can be delivered through the skin by use of a patch. It is a powerful drug that should be taken only by persons already on an opioid medicine whose bodies are tolerant to narcotic medication and who need further pain control.

Fentanyl Transdermal System Side Effects

The powerful medication, when misused, can cause serious side effects in certain patients who are at risk. When released faster than intended, patients can experience harmful or fatal side effects.

The harmful Fentanyl side effects include:

• Excess sedation
• Depressed breathing
• Slow breathing
• Apnea or temporary failure to breathe

Because of its potency, this drug must be handled carefully. It is to be applied exactly as directed to a hairless region of the chest, back, side, or outer side of the upper arm. The area should not be shaved, but if hair is present it may be clipped with a scissors. Anything, such as shaving, that might abrade the skin and cause the medication to be released more quickly must be avoided.

If the area where it is to be applied must be washed, only clear water, without any soap should be used. In addition, no other substances such as oils, lotions, alcohol or other chemicals should be applied to the area as they might increase the absorbency of fentanyl.

Patients are cautioned to:

• Apply the patch to a different region of skin when applying it after removing a previous patch
• Wear it for up to 72 hours, but no longer
• Never wear more than one patch at a time
• Not use a cut or damaged patch, because it could lead to a life-threatening overdose
• Keep the patches at room temperature
• Keep them away from children or animals to whom they could be fatal if sucked on or swallowed
• Be aware that fentanyl is a drug of abuse and should not be used by anyone else in the household
• When disposing of the patch, fold it with the sticky sides together and flush it down the toilet

Fentanyl Overdose Symptoms

If anyone accidentally has swallowed the medication or taken an overdose, they should be taken to the emergency room immediately. Symptoms of a fentanyl overdose include

• Slow breathing
• Extreme weakness
• Extreme dizziness
• Fainting
• Pinpoint pupils
• Cold and clammy skin

The generic name for the drug is fentanyl transdermal. Brand names for the medication are:

• Duragesic
• Duragesic-100
• Duragesic-12
• Duragesic-25
• Duragesic-50
• Duragesic-75
• Sublimaze
• Actiq
• Ionsys
• Fentora

What Fentanyl Transdermal Systems are Recalled?

The following lot numbers are included in the Fentanyl recall:

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

It is made in the United States by Corium International for Actavis.

Have You been Harmed by a Recalled Pain Patch?

If a recalled Fentanyl pain patch has harmed you or a loved one, you may be eligible to seek compensation for your injury. Contact a Fentanyl lawyer for more information today. We can be reached at (800) 889-3898, or send us an email and we will get in touch with you shortly.