McNeil Announces Voluntary Recall
Last night, the McNeil Consumer Healthcare business of Johnson & Johnson announced the voluntary recall of certain lots of over-the-counter infants’ and children’s products. In their press release, the company said the following that explains why this is happening:
“McNeil Consumer Healthcare is initiating this voluntary recall because some of these products may not meet required quality standards. This recall is not being undertaken on the basis of adverse medical events. However, as a precautionary measure, parents and caregivers should not administer these products to their children. Some of the products included in the recall may contain a higher concentration of active ingredient than is specified; others may contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles. While the potential for serious medical events is remote, the company advises consumers who have purchased these recalled products to discontinue use.”
A complete list of the products involved and additional information about the recall can be found on their website, www.mcneilproductrecall.com or by calling 1-888 222-6036 (Monday-Friday 8 a.m. to 10 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time). Any adverse reactions may also be reported to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.
UPDATE: There have been some questions about refunds. I wanted you to know that at McNeil’s recall related website www.mcneilproductrecall.com – a product refund or coupon can be requested.
18 Responses to “McNeil Announces Voluntary Recall”
May 1st, 2010 at 11:06 pm
But what should consumers do with the products they have? Return them to the store? To J&J?
May 2nd, 2010 at 5:31 pm
Ed — thanks for your comment. Refund information is available at the website McNeil created for the recall — if you go to http://www.mcneilproductrecall.com you can request a product refund or coupon.
May 2nd, 2010 at 8:03 pm
Hello Marc,
I started a group on Facebook so that parents could voice their concerns in regard to your recall. This group is the link attached to this posting. Furthermore, I would highly recommend that J&J and McNeail Consumer Healthcare take a serious look at how you’ve handled this situation thus far. To be specific: your recall announcement at 9:15 pm on a Friday night was deliberate to minimize media exposure. You know very well that consumers watch very little news during the weekend compared to a weekday. Your hopes that this will be “played out” come Monday morning is completely irresponsible. Your press release was vary vague not detailing what products have which issues nor how extensive these issues have become. There are a lot of angry parents whom need additional information and I hope you’ll come clean. Until that time, I will do whatever I can to be the REAL story to light. If any questions please feel free to contact me.
In addition, I’ve notified all members of the group and posted what I wrote on your blog so if they visit here and don’t see this posting they’ll know that you deleted it.
Regards,
Evan D. Owen
May 3rd, 2010 at 12:52 am
Evan,
Thank you for reaching out to us. You raised serveral concerns that I wanted to address. The reason the press release was issued late on Friday was because we always work in alignment with the US Food and Drug Administration before issuing any statements. We also reached out to serveral members of the mainstream media Friday night and Saturday morning to make sure they were aware of the announcement. We do make sure that the news media has access to our press releases so they can get the news out to parents like you.
In addition, I understand that you — and others — had trouble getting in touch with someone to speak with at our customer information line. On behalf of everyone at McNeil, I apologize for the frustration, inconvenience and concern that this caused you and other families who were searching for information about the recall. Responding to your questions is extremely important to us, and to improve our response time to consumers we are continuing to add to these resources, including adding additional information and response mechanisms to the http://www.mcneilproductrecall.com site and also increasing toll free information line staffing.
Our interest now is to make sure you and all of our customers have the correct information about this product recall. With this in mind, pleased don’t hesitate to contact us — either via the 1-888 222 6036 number or through our website if you have any questions, if you’d like additional information, or if there is anything else we can do for you.
May 3rd, 2010 at 6:53 am
Mr. Monseau,
I appreciate your response. Please provide me with a contact person at the FDA that can confirm your press release coming out at 9:15 pm Friday night was the result of being in alignment with them. If your intentions were to make sure as many people as possible were aware of this you would have argued not sending the press release out at that time and wait until this coming week. After all, the recall is not the result of any “adverse medical events” so what’s the risk in waiting a few days? Also provide me with the names and contact information of the mainstream media to which you are referring to. Feel free to send these to my personal email so you aren’t broadcasting them on this public blog.
Q: How many NDC numbers/products that were made in Pennsylvania and Las Piedras, Puerto Rico not recalled? Are we talking half of them or all of them, etc.?
The customer information line will give us nothing more than what we can find on your press release. We both know that. These associates are data collectors and coupon issuers. I suggest creating a new press release that provides some transparency as to what is going on, if not, I fear your brands will be more tarnished than the Tylenol incidents of 1982. In these situations, you had outside influences causing the issues. Your current issues are self inflicted thus we can’t trust your company. Come on, you’ve had multiple incidents at two separate facilities this year alone. If I were you guys I’d be begging to do a piece on 20/20 or Dateline with full disclosure along with a sincere apology from your CEO as well as detailed plans on how you are fixing the issues.
These are our children and babies we are talking about.
Regards,
Evan
May 3rd, 2010 at 8:30 am
Mr. Monseau,
You write, “Our interest now is to make sure you and all of our customers have the correct information about this product recall. With this in mind, please don’t hesitate to contact us” I can tell you that what you refer to as “correct information” is at this point nothing but loose generalities and political language. I just got off the phone with Edwin Kuffner, Vice Pres. of Medical Affairs at McNeil. I asked a number of specific questions. I asked about the FDA regulation process (how were the mistakes found and how was it scientifically determined that medical events were remote?). I asked about what the company is calling “manufacturing residue of tiny metal particles” (what metals and how did they get into the products?). I asked how he knew that it was only tylenol that had higher concentrations of active ingredients. I asked what inactive ingredients were sub-quality and how this was determined. Every single question was met with a political response that amounted to “our press release contains the information that we are willing to give out.” He told me that the investigation was ongoing. I told him that his generalities would only spawn more active imaginations based on what “could be possible” rather than what is true. I told him that it’s not scientific or ethical to simply state that there’s no need to worry. I told him that no one will believe either his word, or the word of a company that handles a recall this way. I told him that we need proof. We need, as you said “correct information.” Hiding information only breeds suspicion and panic. I said all of this – as one father to another – and he chose doublespeak and company loyalty rather than compassion to allay the justified anxieties that he helped to create.
Marc, please tell me how I can get some of this information. Please give me an excuse to buy Johnson and Johnson products in the future. I’m serious. I know some people who work for J&J and they say that you’re a wonderful company to work for. I want to believe that. However, the problem of McNeil’s information and transparency is also J&J’s problem. This is almost as bad as McNeil’s initial problem of contaminated and low-quality products. Please help.
–George
May 4th, 2010 at 2:03 am
If ALL of your product where manufactured in the USA not only would you bring much needed jobs to the U.S. but YOU (MOST LIKELY) WOULD NOT FAVE THIS PROBLEM! That IS what happens when you hire cheap labor…….you get what you pay for!
I am appealed!
May 4th, 2010 at 4:07 am
Evan,
Again, thank you for reaching out to us and sharing your concerns. We do strive to share important product safety information when it becomes available so that consumers can become aware of it as soon as possible. In this case, that meant distributing it on Friday evening. Our top priority now is to ensure people are aware of this news and that they know how they can a coupon or refund for any product that was part of this voluntary recall.
Best,
Marc
May 4th, 2010 at 8:43 am
Marc,
You haven’t responded to any of my questions. Why?
–George
May 4th, 2010 at 9:55 pm
Marc:
It is actually quite disturbing to me that your top priority (after ensuring that people are aware of the news) is that they know how to obtain a coupon or refund. After ensuring awareness of the recall (and frankly, if this is your top priority I am astounded at your lack of ability to accomplish this goal given that yesterday, several days after the recall, most of the people I spoke to, many of whom are parents of youg children, knew absolutely NOTHING about the recall), your top priority should be ensuring that people have access to information to address their concerns. The information in the recall is frustratingly vague, and the individuals answering the phone lines apparently do not have authority to do anything more than repeat the (lack of) information in the press release.
You have not actually shared any meaningful product safety information. I have many of the same questions as George.
What exactly are you doing to ensure that those questions will be answered?
May 4th, 2010 at 10:12 pm
Please provide us with more details of the findings. I am a mother of a child that has been using your products (zyrtec, benadryl, tylenol and motrin) for almost 6 years, daily. I trusted and confided in your long standing name and reputation, but am feeling very uncomfortable and frustrated that not more has been done in reaching out to the pharmacies and stores that carry your products, and that I don’t believe J & J or McNeil has shared detailed information to calm our fears as to wha the “particles” were in the bottles, I wish I had kept the bottle of zyrtec that I had found particles in, but I brushed it off because I hadn’t heard anything…now that it was announced late on a Friday night and the lack of direction and assistance from these two companies leaves me wondering how do I know if you take our children’s health seriously. When will McNeil release the findings that the FDA discovered that lead to the recall? I think it is only fair that we, the conusmers that pay for your products are given that information.
Thank you for your time, and please help us believe in a company that we relied on for health and safety.
May 4th, 2010 at 10:37 pm
George:
Thanks for your comments. We appreciate your feedback. I apologize that we are not able to provide you with more answers at this time. As dr. Kuffner explained, we are continuing to investigate these issues and we have shared as much information with you that we can. If you have concerns about the recalled product and your daughter’s condition, please contact her healthcare provider.
May 5th, 2010 at 11:18 am
[...] in the process — is resulting in parental frustration. Evidence:Â Evan D. Owen on the J&J blog: [Y]our recall announcement at 9:15 pm on a Friday night was deliberate to minimize media exposure. [...]
May 7th, 2010 at 11:42 am
[...] house all together.  Several parents went directly to the source and posted their concerns on JnJBTW, a blog managed by Marc Monseau, one of J&J’s senior media relations executives. One parent [...]
May 12th, 2010 at 1:21 am
<<<<>>>
..WHAT….you noticed foreign particles floating around in the bottle of medication that you have been administrating to your child and DECIDED to “just brush it off”. That itself is of more bad judgment on your part than what you are screaming foul on McNeil.
May 18th, 2010 at 11:10 pm
[...] to this post, he has responded to readers in relation JNJBTW posts on this topic (see “McNeil Announces Voluntary Recall“). Edwin Kuffner, MD, Vice President of Medical Affairs at McNeil Consumer Healthcare, has [...]
May 19th, 2010 at 11:38 am
Marc:
It is actually quite disturbing to me that your top priority (after ensuring that people are aware of the news) is that they know how to obtain a coupon or refund. After ensuring awareness of the recall (and frankly, if this is your top priority I am astounded at your lack of ability to accomplish this goal given that yesterday, several days after the recall, most of the people I spoke to, many of whom are parents of youg children, knew absolutely NOTHING about the recall), your top priority should be ensuring that people have access to information to address their concerns. The information in the recall is frustratingly vague, and the individuals answering the phone lines apparently do not have authority to do anything more than repeat the (lack of) information in the press release.
You have not actually shared any meaningful product safety information. I have many of the same questions as George.
What exactly are you doing to ensure that those questions will be answered?
May 19th, 2010 at 11:57 am
Has anyone else had issues with the amount of their refund? I had to destroy 6 various McNeil products and received a check for $10.
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