Recall for Tylenol, Motrin and Other Drugs Issued Due to Moldy Smell
Johnson & Johnson has expanded a Tylenol recall issued last month, to include Motrin, Rolaids, Benadryl and a number of children’s products because of a moldy smell caused by chemical contamination, which has sickened dozens of people.
The expanded Johnson & Johnson drug recall was issued on Friday, as FDA officials criticized the company for failing to promptly investigate the problems and issue the recall, noting that Johnson & Johnson has been receiving consumer complaints since 2008. In a warning letter issued last week, the FDA called the company’s investigation and response to the problem unjustifiable. The most recent recall came only after the FDA, which does not have the authority to force a mandatory recall, pressured the company.
The recalled products include Children’s Motrin, Children’s Tylenol, Motrin IB, Benadryl, Rolaids, Simply Sleep, St. Joseph’s Aspirin and a number of Tylenol products, including Tylenol Arthritis, Tylenol PM, and 8-hour Tylenol. About 500 lots in all of the drugs were recalled in the U.S., the United Arab Emirates and Fiji. A full list of the recalled products (PDF) is available from the FDA.
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Learn MoreThe drugs have been contaminated with a chemical called 2,4,6-tribromoanisole, which is believed to come from a pesticide and flame retardant used to treat wooden pallets. The FDA reports that about 70 people have complained of moldy smells from the medicines, many of whom experienced signs of gastrointestinal distress including nausea, stomach pain, vomiting and diarrhea.
The recall is an expansion of a prior Tylenol caplet recall issued late last year for the same problem. That recall was limited to Tylenol Arthritis Pain Caplets sold in 100-count bottles with a red EZ-Open cap.
On Friday, the FDA issued a warning letter to McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson, saying that the company had failed to properly investigate numerous complaints, failed to expand its investigation when it knew cross contamination was possible and had to be pushed to recall products for consumer safety.
“Your initial investigation into the root cause of the odor was unjustifiably delayed and terminated prematurely. Numerous complaints were received over a four month period in 2008 before they were considered a trend and before actions were initiated to determine the root cause,” the FDA warning letter states. “When microbiological testing in August 2008 did not support an initial speculation that microbial contamination was the root cause of the odor, the investigation was closed. No other possible root causes were pursued.”
The FDA said it is concerned about the company’s treatment of the problem because it raises questions about how Johnson & Johnson handles the quality, safety and integrity of its products. The company has 15 days to respond to the letter.
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KeleyAugust 19, 2010 at 2:47 am
I took "Motrin IB" to releif my head pressure due to bad headache. 12hours later, my sperm and urine smell like rust and have acidic stomach! This is clearly a 2,4,6-tribromoanisole chemical poisoning.
MamieMay 29, 2010 at 4:34 am
In Nov.09, Sams club gave me a recall message on Children's Liquid Tylenol, I called McNeil several days before able to get anybody. Was told the bottle I had was okay to use (I have names and reference numbers. I also have the bottle and the box). On Apr. 29, '10, I gave my granddaughter, 11, this product, within 30-40 minutes, she had a rash on her lower back and told me that she felt bad and co[Show More]In Nov.09, Sams club gave me a recall message on Children's Liquid Tylenol, I called McNeil several days before able to get anybody. Was told the bottle I had was okay to use (I have names and reference numbers. I also have the bottle and the box). On Apr. 29, '10, I gave my granddaughter, 11, this product, within 30-40 minutes, she had a rash on her lower back and told me that she felt bad and couldn't explain how, but felt bad all over. On May 1 or so, I got another recall message from Sam's (still on my answering machine). On May 1, my granddaughter had severe stomach cramps, problems urinating, & back pain over right kidney. I started calling McNeil about this 2nd recall. I was told, "Product did not meet "Johnson & Johnson's" standards, and that it had a higher concentration of motrion, also had tiny particals in it." When I repeatedly asked what the particles were, no one at McNeil couldn't tell me other than it was under investigation. I called the FDA Office in Birmingham and they did not know what the particles were either. On May 17th, '10, I was so mad, when I spoke to a gentleman at McNeil, that he finally told me the particles were metal shavings. We took our granddaughter to her family doctor the next day. They X-Rayed her stomach, did a urine test, & thank the good Lord the stomach showed no metal and the urine tested "OK". However, she has had constipation problems, which she is now taking medication for. Since then, she has missed more days of school than normal. The FDA did an inspection of the McNeil Plant in Fort Washington, PA. and found the metal shavings problem off of equoment being used to make this product. I am so mad at these companies making huge profits and lying to cover up the truth about the dangers posed by these contaminated products. The FDA is not doing their job well.
stacyMay 1, 2010 at 11:28 pm
I used coumadin for a while years ago and I had to use tylenol for aches and pains. I haven't been on coumadin for years, but just out of habit always buy tylenol. Well for about 4 months I had been having gastro intestional problems( Now this has been going on over a year.) I thought it was something I was eating. Until one night in Aug. I had my husband rush me to the hospital. I thought I was [Show More]I used coumadin for a while years ago and I had to use tylenol for aches and pains. I haven't been on coumadin for years, but just out of habit always buy tylenol. Well for about 4 months I had been having gastro intestional problems( Now this has been going on over a year.) I thought it was something I was eating. Until one night in Aug. I had my husband rush me to the hospital. I thought I was dying. The pain was so severe my jaw was quivering. The doctors checked me out and said I need an utra sound. They said I had a gallstone and I had my gallbladder removed. But even after the gallbladder removal I still have severe pains. I have had tests done and been back to the e.r. several times for pain. Then I got the recall email from Mcneil. I am still having stomach trouble and just a couple days ago had to have endoscope and now my doctor wants me to have a colonoscopy. I am only 31. The medical bills are piling up. I don't think it is fair if the drug is to blame for my problems, for me to have to go through so much and pay all these medical bill, because I trusted a big name drug. Shame on you tylenol. I hope you are listening to us. We are hard working people, raising children and were once healthy. We trust your drug to take care of the occassional ache or pain, even a headache or two. I think you should be held responsible, at least pay my medical bills. I filled out a paper saying for Mcneil to get access to my medical records and have not heard back from anyone. I actually went to the E.R. again one morning for the severe stomach pain just a few months back, even after my surgery, I still have the stabbing, burning in my upper stomach, I was there for several hours, that afternoon when I got home is when I recieved the email from Mcneil. I have medical records to prove my pain. I think everyone dooped by this company should get some kind of componsation. I am very displeased with this company, and now don't know if I will ever trust them again.
EdwinaApril 13, 2010 at 6:20 pm
I was taking Motrin 3 to 6 pills a day for rheumatoid arthritis. I had the moldy smelling 300 count bottles. I started having severe stomach pain that increased in intensity and frequency over time. I saw a gastrointestinal doctor and had a colonoscopy. I went to the emergency room and had a cat scan and blood testing prior to knowledge of recall. These stomach aches were so painful that I would n[Show More]I was taking Motrin 3 to 6 pills a day for rheumatoid arthritis. I had the moldy smelling 300 count bottles. I started having severe stomach pain that increased in intensity and frequency over time. I saw a gastrointestinal doctor and had a colonoscopy. I went to the emergency room and had a cat scan and blood testing prior to knowledge of recall. These stomach aches were so painful that I would not move and scream for one hour. I wouldn't let my children or husband call 911 because I was terrified of them touching me or trying to move me. This went on for months culminating in December when I heard about the recall and quit taking Motrin. At this point I was not recuperating from these bouts of stomach pain and they were coming weekly. I seriously thought I was dieing and told my doctor I couldn't live with this anymore. I quit taking Motrin and the pain ended. Its been three months since I had those horrifying stomach aches. I had a stomach ache (mild) just recently that resembled the past and was worried about residual effects of this chemical. My gastrointestinal doctor also checked my liver which is fine but said there is no test for this chemical.
jenniferFebruary 11, 2010 at 10:47 pm
I also took this Motrin. My husband kept getting sick like stomach, but I had a problem with my left eye and down my jaw and gland. This started at the same time I started to take the Motrin, and started to ease up after Sam's sent me a letter telling me to stop taking it. I had the big mega 300 size bottle, so, I have been taking this stuff AT LEAST every other day since around August, as the[Show More]I also took this Motrin. My husband kept getting sick like stomach, but I had a problem with my left eye and down my jaw and gland. This started at the same time I started to take the Motrin, and started to ease up after Sam's sent me a letter telling me to stop taking it. I had the big mega 300 size bottle, so, I have been taking this stuff AT LEAST every other day since around August, as the pain in my gland and jaw was horrific. I hurt, I took this, I hurt some more, I took the Motrin again---a vicious cycle. For the past few days the symptoms seemed to ease up. I have been to my doctor twice, my dentist, an ears nose and throat specialist, who did an MRI, and an eye doctor who prescribed glasses for the other eye since I strained it so much--I now need glasses. I am 39 but I have never needed them before. I am EXTREMELY allergic to mold so, Like Maryjane asked what do I need to be tested for? I still have mild problems. What is it that was in the Motrin? What do I need to tell my doctor/testhe should run. P.S. I wouldn't mind trying to get my 500.00 in co-pays and doctors fees back, if this is what did to me.
maryjaneJanuary 24, 2010 at 11:51 pm
i took this med for months i didnt no that it was the cause of my gas and pain problems i stoped taking it last week im still sick with gas pain have no desire to eat i trusted these pills now im a mess the lot number was on the recall but when i called the company they asked for experation date they said my bottel was fine and thats a lie and all the other bottels i thew away plus the benadryl i [Show More]i took this med for months i didnt no that it was the cause of my gas and pain problems i stoped taking it last week im still sick with gas pain have no desire to eat i trusted these pills now im a mess the lot number was on the recall but when i called the company they asked for experation date they said my bottel was fine and thats a lie and all the other bottels i thew away plus the benadryl i was talking in the summer when this all begain i have been in pain for7 months down in bed what can i do, this company needs to pay for all that losts time and all this pain every day i wake up i pray not to be in pain what should i be tested for maryjane queeno
TadJanuary 21, 2010 at 12:12 am
On Saturday 01/09/10 I took Tylenol Extra Strength Caplets (Lot#AJA175). I soon became dizzy followed by severe vomiting, diareha, stomach cramps and fever. The next day I was taken to an urgent care unit and treated for dehydration and what they believed at the time was a G.I. infection. My symptoms persisted until Wendesday 01/13/10. I missed two days of work and had to pay for my treatment.[Show More]On Saturday 01/09/10 I took Tylenol Extra Strength Caplets (Lot#AJA175). I soon became dizzy followed by severe vomiting, diareha, stomach cramps and fever. The next day I was taken to an urgent care unit and treated for dehydration and what they believed at the time was a G.I. infection. My symptoms persisted until Wendesday 01/13/10. I missed two days of work and had to pay for my treatment. No one who came into contact with me became ill.
sonnyJanuary 19, 2010 at 3:04 pm
this is to the fda if you guy's can not do anything to these drug companies then you need to be dismantled and a new thing set up that can go after these drug companies that poison the public in general but to tell you the truth i believe that our government is in on this to thin out the population and it is a damn shame that the congress and the senate and all the rest of the assholes running thi[Show More]this is to the fda if you guy's can not do anything to these drug companies then you need to be dismantled and a new thing set up that can go after these drug companies that poison the public in general but to tell you the truth i believe that our government is in on this to thin out the population and it is a damn shame that the congress and the senate and all the rest of the assholes running this country just don't give a damn about us they just accept the money handed to them by these companies and turn their sorry ass head the other way.but i tell you one thing GOD ALMIGHTY does not want nor need thier money and people will burn in HELL for what they are doing to the general public!!!!!!!!!!!!