Mylicon Recall: Infants’ Gas Relief Drops Could Contain Metal Fragments
November 11th, 2008 • Filed Under: News, Recalls • 20 Comments
Approximately 12,000 plastic 1 ounce bottles of Infants’ Mylicon Gas Relief Dye-Free Drops (simethicone-antigas) sold since October 5, 2008 have been recalled after it was discovered that some of the bottles could contain metal fragments.
Mylicon gas relief drops are manufactured by Johnson & Johnson-Merck Consumer Pharmaceuticals Co., which is a joint venture between Merck and Johnson & Johnson to market non-prescription products derived from Merck prescription medications.
Infants’ Mylicon is an over-the-counter anti-gas medicine, which is used to relieve the discomfort commonly caused by infants swallowing air or from certain formulas and foods.
Consumers have been urged to immediately stop using any 1 oz plastic bottles of dye-free Mylicon infant drops with lot numbers SMF007 or SMF008, which can be found on the bottom of the box the product came in, or on the lower left side of the sticker on the bottle. The recall applies to products labeled “Infants Mylicon Gas Relief Dye Free Non-Staining Drops 1 oz.” with expiration dates of 09/10.
The Mylicon gas relief drops recall was issued as a precaution because some bottles could contain metal fragments that were generated during the manufacturing process.
In a press release announcing the Mylicon recall, Johnson & Johnson indicated that “the potential for serious medical events is low”, and that if any problems do occur, it is expected that they will be temporary and resolve without medical treatment. However, parents who have given the product to their infant should contact their healthcare provider immediately if they are concerned.
The recall only applies to 1 ounce dye-free Mylicon gas relief drops. Original Infants’ Mylicon Gas Relief products, which are available in 1/2 oz. and 1 oz. sizes, as well as Infants’ Mylicon Gas Relief Dye Free drops non-staining sold in 1/2 oz. sizes, have not been recalled and there is no indication that they may contain metal fragments.
Comment by julie on 11 November 2008:
this is ridiculous! for some babies this is their only relief! my son’s formula has been switched 3 times and Mylicon is the only thing that gives him relief. Not only is this type of neglect not fair to the babies but also the parents who are paying $15 per once for this product. More caution needs to be taken when manufacturing children’s medicine.
Comment by Carol on 12 November 2008:
I am extremely upset!! How long has Johnson & Johnson known about this??? Since October 5, my Grandson has used several 1 oz. bottles. How many peolpe save bottles after the medication is used? I do not know what those lot numbers were!!! According to Johnson & Johnson, “the potential for serious medical events is low and if any problems do occur, it is expected that they will be temporary and resolve without treatment”. This basically tells me that J & J does not know the extent of medical difficulties that can occur through their carelessness.
Grandma
Comment by Carley on 13 November 2008:
My 3 month old little girl HAS to have Mylicon after each feeding for her very sensitive stomach. Lately, she has begun throwing up excessively after eating and taking the mylicon. It never occurred to me that it could be the mylicon, but now I am wondering if that is what has caused her to throw up???
Comment by Anissa on 13 November 2008:
First it was the peanut butter which my daugher who is now 3 was ill for several days after she ingested it, and now this. My infant was born October 4, 2008 and at my hospital they had sent letters out saying that the medical equipment used for surgeries and obsterics were not autoclaved ( the sterilization process after cleaning). We have been nervous since then and now this. I have used these drops since her birth, and I do not keep the bottles. This is ludicrous and negligent to say the least. If metal fragments are in the products that tells me that the machinery used to house the drops is not undergoing mandatory maintenance. Such a shame. Johnson & Johnson is a OLD company and the 2nd largest billion dollar company. This is embarassing for the US to say the least. Very angry parent.
Comment by carrie on 14 November 2008:
Just wanted to remind you that the Mylicon recall is only for the dye-free version of the product and only the 1 oz. version. So, you can still buy the product if you need it without fear in the 1/2 oz. versions OR in the regular, not dye-free versions. So, don’t worry, the babies can still be relieved. Also, simethicone, the ingredient in the product is available in other name brands and non name brands such as Equate from Wal-Mart and the Walgreens brand. Simethicone is all the same and the off-brands are a lot cheaper. The Equate version is 1/2 the price of Mylicon and EXACTLY the same medication. That’s what I use…
Comment by Christie on 14 November 2008:
We’ve been using Little Tummies for over a year with our toddler and have seen the same relief provided as what Mylicon offers…for much cheaper. I’d say switch to Little Tummies and stop using Mylicon with or without the recall…
Comment by Concearned Mom on 14 November 2008:
This is ridiculous! Especially for a highly trusted company like Johnson & Johnson. The bottle says “Safe for every feeding”. Lies!
Comment by Patti on 14 November 2008:
This is totally outrageous. J & J should be fined for this.. It would also be nice if J & J would share what type of metals seemed to have been dropped into the Mylicon which both of my children have used… it better not be lead.
Comment by Steph on 14 November 2008:
I use mylicon with my son also. I was very upset to hear about this. J&J should have kept a closer eye on this.
Carley, you may want to take your little girl in to the pediatrician office. she may have reflux is she is throwing up excessively or it may be the formula, you may want to check with your pediatrician and see if a formula change will help. My son who is 11wks old we just found out he has reflux and a slow emptying stomach which is causing his excessive throwing up. My 2 yr old also had the same trouble.
this doesn’t excuse J&J and i’m not making any excuses for them.
Comment by new mother on 15 November 2008:
Okay seriously I am sure that this is Johnson and Johnson being overly cautious as well… neglegent would be if they didn’t give everyone this fair warning I’m sure all of your children are fine. Things like this probably happen all of the time in factories and no one even knows. If you have already used the bottle and your child is okay it doesn’t matter that you don’t have the bottle still. Mylicon is a great product and has probably helped many of u and your children get sleep at night and I don’t think this means you should stop using it!
Comment by Nelly on 15 November 2008:
This is crazy. Does J&J realize that they are messing with our babies health. I’ve been giving my son this crap for the last 4 months (since birth). I can’t even count how many bottles I’ve gone through. J&J YOU SUCK. Plain and simple. Thanks for nothing.
Comment by Cheryl on 15 November 2008:
Wow Mylicon is pretty vague about what can happen as a result of taking the Mylicon with metal fragments. Stating that “serious medical effects are low, if any” isn’tgood enough. What are the medical effects? My granddaughter has been on Mylicon much since she was about 2 weeks old. She’s now approaching 10 weeks and we don’t have the empty bottles to look at the stock numbers. All we do know is lately she’s been having screaming fits….could they be related?
Mylicon needs to step up and put out what the side effects could be and how much has to be ingested before they set in, etc. Also since this effects infants/babies they need to be more precautionary and pull all their medicine and present more facts.
Comment by Kendra on 15 November 2008:
this is ridiculous my daughter has had 2 one ounce bottles of mylicon since the beginning of september i didnt keep the bottles who would after they are empty? now i have to throw away the bottle i just opened i cant give that to her with the thought in the back of my mind that there still could be something in it! this mistake should have been caught and told about a lot sooner than it has been.
Comment by Allison on 17 November 2008:
I also have been using these since my girl born October 6th, 2008 was born, we started using them maybe a week or two after having her and ever since then she has had digestive problems, she has nearly no bowel movements, her stomach is hard and bloated, she is in very much pain and screams non stop for hours….. my doctor could not figure out what was wrong so we went to a GI specialist and he gave us a laxative medicine that has done nothing… could this be related to the drops? I was using them up until yesterday when i heard.
Comment by Watchdog Mom on 17 November 2008:
For all the whining going on here, has anyone actually linked a single adverse effect to this metal issue? Kudos, actually, to J&J-Merck for recognizing the problem and alerting the public. If you want manufacturers to be held to the standard of perfection, as so many of you do, you’ll quickly find that no one will want to manufacture products (or sell them in the U.S…where lawsuits are rife) that might actually HELP your child’s symptoms and problems.
Comment by Lola on 17 November 2008:
What is so sad about this is it isn’t just J&J who are putting Americans at risk, It is the food we eat the vaccinations we get its everything now a days what a shame =(
Comment by BeLInda on 20 November 2008:
My grandson of 3 months was admitted to the hospital 3 times in the month of November. The last admission is when the dr. discovered my daughter was giving him mylicon drops for his gas. His formula was changed and the mylicon drops were discontinued. He was discharged on Nov. 18, 2008. He is feeling better but I wonder what kind of metal and has it already caused him problems??
This makes you wonder if this is making our babies sick what are other medications doing to our adults????
Comment by Kassie on 26 November 2008:
I have a 3 week old that i give mylicon all the time! She has started throwing up more often and i think it is the mylicon! She is not a fussy baby and here lately she has been crying for no apparent reason! I am wondering if this has to do with the fragments of metal that were found? I am very upset about this!
Comment by Tonia on 3 December 2008:
This is unbelievable! I put my son on these when he was 2 weeks old. He is such a good baby. He never cried or fussed over anything unless he was hungry but after about a week of being on these drops he started crying all the time and having belly aches. I’ve had him off the drops since the recall but he still spits up all of his milk and keeps his legs drawed up like he’s in pain. When I called his Dr. after I called the company the dr, refused to see him and said he would be ok. But I can tell that he has just not been the same since. Makes you wonder if theres anything out there you can ever trust to give your kids. I will never use another j&j product again.
Comment by Maranda on 18 December 2008:
This is uncalled for. my son needs this med. He has used it since he was 2 months old. He has had his formula switched 4 times he is now 6 months old. They found a formula that doesnt make him sick of bleed from his intestines and its 50 dollars a can, almost 1000 dollars a month. And my husband makes 26 dollars more then allowed for assistance. But that income is based on someone that has normal formula that is the cost of 10-15 dollars a can. But he has to have this formula its the only think that works. And it makes him very gasy, there for he needs this meds to be able to stay calm. And now i cant use it. Now all my son does is scream and cry pretty much all day cause he is in pain. He only sleeps about 4 hours A DAY now, which is not good since he is suppose to sleep anywhere from 10-14hrs a day. There for my husband and i get no sleep either. I think JJ should be very disapointed in there selves. They should take better percautions with there products seeing how its for Babies and Childern. They must not care very much. Not to mention that like the other person stated, I dont keep the empty bottles how am i suppose to know if he took in bad bottles. he has went threw atleast 2 a month since july. I want to know what medical risk my child is maybe going to get or has got or going threw and no one knows about now. This could be the reason behind a lot of my sons medical problems that he has had since he was 2 months old. This is really upsetting.