Watson Fentanyl Patch Recall
Published: August 13th, 2008 • Comments: 12
Watson Pharmaceuticals, Inc. has issued a recall for one lot of its generic 75 mcg/hr Fentanyl Transdermal System patches after they discovered some of the patches leak Fentanyl gel, which could cause a life-threatening fentanyl overdose if the gel comes in direct contact with the skin.
The Fentanyl Transdermal Patch is used by patients who require continuous relief from chronic narcotic pain, which cannot be treated with less powerful pain medicines or less frequent dosages. Fentanyl Patch is a narcotic analgesic. It binds to receptors in the brain and the nervous system, which are used by the body’s natural pain relievers. The Fentanyl patches involved in this recall are generic versions of the Duragesic patch, which was introduced by Johnson & Johnson in 1994.
The Fentanyl in the patches is designed to be contained between sealed layers of the patch. The patch is supposed to be applied to skin once every 72 hours, and slowly release the Fentanyl gel for continuous pain relief. However, Fentanyl is a powerful opioid painkiller, and if the gel comes into direct contact with the skin it could cause respirator depression, fentanyl overdose or death.
The Watson Fentanyl patch recall involves one lot of their 75 mcg/hr patches, which contain an expiration date of August 31, 2009 and lot number 92461850. The affected lot of Fentanyl Transdermal patches were shipped to customers between January 30 and March 19, 2008.
According to a press release issued by Watson, a small number of patches were found to be leaking fentanyl gel, which could expose patients wearing the patches or caregivers who may help apply them, to a substantial risk of injury. However, there have been no confirmed reports of injuries associated with the recalled generic Fentanyl patches.
Earlier this year, several other manufacturers recalled Fentanyl patches due to concerns that they may be leaking fentanyl gel. In February, Johnson & Johnson recalled millions of 25mcg/hr Fentanyl patches sold under the brand name Duragesic and as a generic by Sandoz, Inc., after they discovered that patches were leaking because they were not properly cut during the manufacturing process. Weeks later, Actavis, Inc. issued a recall for all lots of their 25, 50, 75 and 100 mcg/hr fentanyl patches sold in the United States because some were found to contain an internal folding defect, which could allow the gel to leak onto the skin.
There have been hundreds of reported Fentanyl overdose deaths which have been linked to the pain patches since they were first introduced. In addition to manufacturing defects, the FDA has issued several prior warnings about the proper use of the Fentanyl patch and about reports of serious and fatal injuries suffered by users.
Users who have been prescribed the Fentanyl patch have been urged to check to make sure any patches they have are not impacted by the recall. Given concerns about the widespread manufacturing problems with the Fentanyl Transdermal System, users and caregivers should carefully check any patches that they use for leaking gel. If Fentanyl gel comes into contact with the skin, the FDA has recommended that the skin be thoroughly washed with water only, not soap.
Comment by gerald on 19 January 2009:
im in a s#*tty situation. my insurace company, which i will not say, has stopped covering the price for the fentanyl patch brand Myland because the price went up. so now im stuck with the brand Watson, which according to this web page, has a recall because they leak! so my insurace company would rather save a few bucks by not covering Myland patches and only cover patches with may or may not have a defect. what a croc! i cant even go to another pharmacy because my insurance will not kick in at any other. talk about playing russian rolette with someones life! all in the name to save a few bucks to make sure the ceo’s of drug and insurace companies can afford their summer houses in the hamptons and send there demon offspring to the best colleges our lives can buy. i would like to know when our lives have began to mean so little to the companies who we pay billions and billions of dollars to every year to help us stay alive and well. the crappy thing of it all is that i NEED the patches to functon somewhat noramlly without being in agonizing pain. what really pisses me off is that im sure they know many people are in the same situation im in yet continue these, some would say, immoral practices.
Comment by MARILYN on 25 February 2009:
I KNOW OF THREE PEOPLE WHO HAVE PROBLEMS WITH THIRD DEGREE BURNS WITH THIS PRODUCT, INCLUDING MYSELF.
Comment by Steve on 3 March 2009:
How does one get thrid degree burns with a pain patch? If one is using a heating pad and being a bit over dosed one should be very careful. Heat from a heating pad/electric blanket etc. can cause excess fentanyl to be released and one can get seriously overdosed.
I had the original Janssen Duragesic pain patch 50mcg/hr when in low-rentsville West Virginia and it was very easy to use, very effective and very easy to stay compliant with. Now back in California I am on Methadone 60-90mg every day in 20 to 30mg divided doses.and am supposed to stay to a rather strict mean of 70mg every day. I am supposed to use 5mg or maybe 7.5mg and rarely 10mg oxycodone for brreakthrough. If one has one of those 7.5+ on a scale of 1 to 10 pain days it is hard as all get out to keep all that straight. I really miss Duragesic. I know it is not for every one and can be quite dangerous and has to be used with care and caution but for many of us it was a blessing from heaven above/the holy godesss tara or whoever via Jannsen Pharmacuetica.
Comment by vicki on 5 March 2009:
my brother died june 7, 2008 due to a fentanyl patch overdose. He was 34 years old. From all the research I’ve done these patches are seriously dangerous.
Comment by L Curry on 2 April 2009:
My mother passed away in May of 2008.She was on the patch.I was never informed of the deaths of people using this.
Comment by marilyn on 17 April 2009:
I am another Marilyn who knows three people including myself who have had the third degree burns. I also had a problem with the product sticking.
The sticking problem, and the burning left me three patches short one month.My doctor’s office said “oh, well just make due”.
I went to the emergency room two days later with severe withdrawal syndrome and went into a seizure.I was in the hospital four days.
Now, I have to find a new doctor.
Comment by laura on 31 May 2009:
my brother died march 17 2009. he was only 56yrs old the m.e .reported his death was from a lethal amount of fentanyl. he had put on a patch the night before he passed
Comment by Courtenay on 17 June 2009:
I am on the Fentanyl Transdermal System by Mylan (50 mcg.hr) and this patch hased worked great for me. It has no gel in it. So if you are a person who just likes lawsuits or wants to eat the gel and get buzzed you probably won’t care for this patch!
Comment by FLOYD on 12 July 2009:
I HAVE BEEN USING 50 MG. PATCHES FOR SEVERAL MONTHS, AND THEY HAVE DEFFINATELY HELPED ME WITH MY PAIN. IT HAS HELPED ME CUT BACK ON MY REGULAR PAIN MEDICINE, AND HAS COMPLETELY STOPPED MY RESTLESS LEG SYNDROME? BUT I ‘AM
VERY CONCERNED ABOUT THESE DEATHS AND RECALL’S! DOES ANYONE HAVE ANY GOOD ADVICE FOR ME? I’AM CONTACTING MY DOCTOR AND PHARMACIST IMMEDIATELY.
Comment by connie on 28 July 2009:
the safest form of this patch would be the mylan brand,as it is the matrix type patch so there is no gel to overdose on,i also am on methadone and have been on the patch. its been a few months since i used this patch,but i completely agree with Courtenay. if you have a serious issue with pain then this works wonderful,but i really would suggest going with the mylan brand. and for the person who’s insurance won’t pay for this brand,your dr can and will appeal a denial as long as they don’t feel you are abusing it. also it shows me the price of this medication if i didn’t have insurance and its not expensive at all! the most important thing is…do NOT abuse this medication,which my dr told me people are actually taking the gel and shooting it up./..or chewing the patches! do these morons have a death wish? i can’t handle a patch even above 50mcg! and,i was also lucky enough to not have withdraws,but i’ve also been on methadone. so i just would like to say,thank you to the pharmaceutical companies that are responsible and actually CARE about the people taking these medications!
Comment by LeeAnn on 10 February 2010:
I’ve using the fentanyl 75mg patches for about a month and a half. By the second day they are itching and by the time that I take them off there is always a rash so I just keep moving them to new areas. However, I had one that was itching terribly. When I took the patch off it was full of little blisters. The blisters faded somewhat then started to dry out a little. But the rash/burn won’t go away. My dr can’t even figure out what happened my skin. Meanwhile my skin itches, burns when anything is put on it(even water) and keeps swelling and peeling away. Almost like a cycle, and no over the counter creams/ointments even perscription stregth are helping. I am terrified that I am going to be left with a scar because it really appears to be a serious burn. Maybe this has happened to you or somehow someone out there can tell me what to do. Unfortunetely I have to continue to use them until I can get in with a pain specialists because the withdrawls are beyond terrible.
Comment by dolly on 12 March 2010:
I understand about the burned marks left on your skin because its hard to get your skin clean. I just received my Batch of fentanyl 50 mcg/h from Walmart because they were less than CVS and when I opened it there was nothing in it. That is how I came t this sight and after seeing and reading all this it makes me leary. I was informed by the pharmcist Tyler at Walmart to contact Watson manufacturing company. Does anyone have a direct phone number? Thanks