Johnnson and Johnson recall medicine for infants and children

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Lyndsey Layton
Washington Post Staff Writer
Monday, May 3, 2010; 1:00 PM

A division of Johnson & Johnson is recalling 43 over-the-counter medicines made for infants and children -- including liquid versions of Tylenol, Motrin, Zyrtec and Benadryl -- after federal regulators identified what they called deficiencies at the company's manufacturing facility.

Washington Post staff writer Lyndsey Layton was online Monday, May 3, at 1 p.m. ET with the latest information on the recall.

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Lyndsey Layton: Hi everyone,

This massive recall is sparking a lot of questions among parents and others, so let's get to yours right away.

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Providence, R.I.: Has McNeill said what consumers should do with tainted products? Can they be returned somewhere for a refund or voucher?

Lyndsey Layton: Hi Providence,

McNeil is offering either a refund or a coupon for free replacement medicine in the future. Details are available at the company's website http://www.mcneilproductrecall.com

The company and the FDA advise consumers to stop using the medicine and dispose of it. The FDA has some tips about safe disposal of meds at http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/EnsuringSafeUseofMedicine/SafeDisposalofMedicines/ucm186187.htm

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Rockville, Md.: What is the mechanism for getting refunds for the medications I purchased, but cannot use?

Thanks.

Lyndsey Layton: Hi Rockville,

The company's website lists the refund and rebate information (see response to the first questioner below) but as I understand it, you may be eligible for either even if you no longer have the product in hand but have proof of purchase.

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Rockville, Md.: Are generic versions (house brands) of the medications also being recalled?

Lyndsey Layton: Hi Rockville,

No, this recall does not include generic versions of the drugs. The FDA says they are safe to use. The generic version of Tylenol is known as acetaminophen. The generic for Motrin is ibuprofen; for Zyrtec, it's cetirizine; and for Benadryl, it's diphenhydramine.

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Bethesda, Md.: Hi -- I have looked at the recall information and noticed that the children's chewable Benadryl does not seem to be included in the recall. Is this correct? Is it made in a different factory? Is there anything to be concerned about in using it? My son has bad food allergies so Benadryl is an important medicine!

Also, are the generic brands of children's benadryl and tylenol liquids still okay to use?

Thanks!

Lyndsey Layton: Hi Bethesda,

The factory that produced the products involved in the recall makes liquid pediatric formulas, not solids (chewables, tablets, etc.) If the product is not on the recall list, it's OK to use.

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Leesburg, Va.: My son took Zyrtec a few weeks ago and had a terrible reaction --stomach pains, terrible mood swings and total lethargy. His pediatrician said that some people react badly to Zyrtec, so I took him off. He was on and off it two different times before I made the connection that the Zyrtec was causing the problems. He has been back to normal since going off it, but I'm concerned that perhaps he had Zyrtec with a higher concentration of the active ingredient or some impurity that caused these problems. I am worried about any long-term affect on his health. I threw out the Zyrtec after the doctor said that it was probably causing the symptoms. Do I have any recourse at this point? We had to take him to the ER and to the regular doctor for his symptoms. Also, what are the "particles" that may have been in the medicines?

Lyndsey Layton: Hi Leesburg,

That sounds like a rough episode. I'd call back your pediatrician, in light of the recall, and discuss it with him/her and I would also contact the FDA to let the agency know you suspect your son had an adverse reaction to a recalled medication. There's a link in our story to the FDA website page where adverse reactions can be reported by parents or doctors.

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washingtonpost.com: Disposal by Flushing of Certain Unused Medicines: What You Should Know (FDA)

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Germantown, Md.: Here we go again with yet another big recall. Why weren't lessons learned after the massive recall in 2009? Where is the oversight? Should we just be sticking to generics?

Lyndsey Layton: Hi Germantown,

This certainly has the potential to damage the brand for Johnson and Johnson because it comes on top of several other recent recalls involving Tylenol.

The same J&J division, McNeil, had a problem late last year and earlier this year with Tylenol made for adults that had been contaminated with a chemical that leached from the wooden pallets that held the product in a different facility. The contamination was discovered after consumers complained of gastrointestinal illnesses, and the company recalled it. The FDA criticized McNeil for failing to address that problem quickly enough.

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Bethesda, Md.: Could my child have been harmed from taking these medications? What are these particles they are talking about? And how much higher were the active ingredient doses?

Lyndsey Layton: Hi Bethesda,

McNeil is describing the particles as "black particles" and we don't yet know what they are. Sometimes, pieces of metal or rubber from the manufacturing machinery ends up in medication or food, and that might be what this is. We also don't yet know how widely the amount of active ingredients varied. The FDA is still investigating and I expect we'll learn more from federal regulators in coming days. But there are two important things to keep in mind - the FDA does not have any reports of illness that it has been able to link to the medicines, and the FDA Commissioner, Margaret Hamburg, is calling the chance for serious health affects "remote".

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Wichita, Kasn.: Does this recall only apply to the brand names? Specifically, are "store brands" like Target and Kroeger products included?

I tried repeatedly to get through on the phone but haven't been able. Can I just take the remaining products to any store for a refund/replacement?

Thanks!

Lyndsey Layton: Store brands are not included in this recall. They are safe to use.

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Manassas Park, Va.: What do we need to get reimbursement for our Tylenol/Motrin that we currently have in our medicine cabinets? I have heard things about reciepts?

Lyndsey Layton: Hi Manassas Park,

If you go to the McNeil website you'll see an area in which the company asks you to fill out information in order to get a refund or coupon for free replacement product. It does not ask for a receipt but it does ask for information that is on the packaging - the NDC # (which is the number beneath the bar code) lot number, expiration date. If you don't have the packaging any longer, but have a receipt, you might still be eligible for a rebate or refund. The company has set up a hotline (1-888-222-6036) to answer consumer questions about the recall and refunds.

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washingtonpost.com: McNeil Product Recall

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Washington, D.C.: Are these medications considered "dangerous" or just not up to quality standards? It's a voluntary recall, right, not mandatory?

Lyndsey Layton: Hi Washington,

That's an excellent question. FDA sources have told me they do not consider this a serious health risk. But anytime there's a problem with a medicine formulated for infants and children, there's heightened concern.

Yes, it's a voluntary recall. But almost all recalls are voluntary because the FDA has very limited authority to mandate a recall.

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Judiciary Square: My dd5 has already finished a recalled bottle of Zyrtec; should I be concerned at this point? She had no side effects, other than the normal drowsiness. This recall has to come too late for many of us, right? Thanks.

Lyndsey Layton: If she had no unusual symptoms, there doesn't seem to be reason for concern.

One thing to keep in mind - Patrick Dougherty, a clinical toxicology fellow at the Maryland Poison Center of University of Maryland School of Pharmacy told me he is most concerned about children who may have had repeated doses of recalled medicines over a period of time,

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Washington, D.C.: I suppose my question is the most obvious -- can we return our bottles to CVS and get a refund until the good stuff returns to the shelf?

Lyndsey Layton: Hi Washington,

McNeil and the FDA are recommending that you dispose of your recalled product (after contacting the company for a rebate/coupon), not bring it to your pharmacy. See below for a link to the FDA site that tells you the best way to dispose of unused meds.

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Bowie, Md.: An FYI about disposal -- I take all my expired or unused drugs to CVS and they have always been fantastic about taking them and disposing them for me.

Lyndsey Layton: Hi Bowie,

As I said a little earlier, McNeil and FDA are asking consumers to dispose of the meds themselves. I think they're worried that the retailers would be buried in a mountain of Tylenol, if you consider the scope of this recall. But if your friendly neighborhood CVS doesn't mind, that seems like a fine solution for you.

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No NDC Number?: Hi, My bottle of infant Tylenol does not have an NDC number that matches the form of any of the lists that I have seen, and we discarded the packaging long ago. Is there any way to know whether it is included in the recall without spending 4 hours on the phone with customer service? The stamped/printed information I do have is: LOT ALM360/EXP 08/11/7843734 Thank you!

Lyndsey Layton: Hi,

I'm afraid McNeil is the best judge of whether that product is part of their recall. I know I'm condemning you to some time on their help line, but I'm afraid it's the only way to know for sure. If there's any bright side, the company was so inundated with calls over the weekend, they put some resources into extra staffing on the hotline, so maybe the wait won't be bad.

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Bethesda, Md.: Our child is on the older side (nearly 12). Is it naive to not be particularly concerned about possible slight dosage differences that seem to be the key basis for this recall? I can see how this might be an issue for a baby or toddler, but seems less relevant for an older child who is effectively taking an adult-strength dosage anyway.

Lyndsey Layton: Hi Bethesda,

Yes and no. Certainly, infants and toddlers are more sensitive. But older kids - even the ripe old age of 11 - are also vulnerable. There is a story just today out of Oregon where some middle schoolers were hospitalized after taking adult-strenght OTC cold meds.

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Annapolis, Md.: For the person who can't find the information -- it is very small, above the word Tylenol -- it is hard to find the numbers on the infant bottles, bc it is so small and nondescript.

Lyndsey Layton: Thanks Annapolis!

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Alexandria, Va.: What kind of symptoms are being exhibited by the children who are having adverse reactions to taking these corrupted medications? I ask because my son (1.5 years) has been taking Zyrtec for over a year and he's gotten a redness around his eyes in the last two months that we'd not seen previously. He's on a generic now, thankfully.

Lyndsey Layton: Hi Alexandria,

Has the redness stopped since he switched to generic? You might discuss this with your ped, and see if you should contact the FDA to tell the agency you suspect he had an adverse reaction.

At this point, the FDA is going through its database of adverse reaction reports to see if any may be connected to the recalled medications, so we don't know yet if any exist. McNeil told me they had received complaints from consumers for some of the medicines in question, and that they had to do with black particles in the bottles, not adverse reactions.

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Lyndsey Layton: Looks like we ran down the clock. Thanks so much for your questions, and for spending the hour with me.

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