Simply Thick Recall

I wonder why none of the pediatricians or even the Children’s Hospital had any knowledge of this “recall”. I got an urgent call from a mother whose son had been on thickeners for 7 years and cannot consume orally without them. A school nurse told her she was killing her son. I asked all of our supply companies and none who supply the Simply Thick had been notified by the company of any recall. They contacted Arkansas Children’s Hospital who uses Simply Thick in a major way and even they had not been notified. So, what is the real deal and why doesn’t the company have to notify distributors or users of the product? If this were Tylenol it would be all over the news!

“A school nurse told her she was killing her son.”

It is important to note that no actual illnesses have been linked to the recall, so that statement is a little extreme.

Getting information out about recalls is always a challenge for companies. I’m guessing they will be sending out a warning letter to their distributors and people who purchased SimplyThick directly from them.

I’ll try to get a more formal answer from some at the company though.

What about the 15 babies who got sick with NEC and the 2 that died?

According to the company:

“1. As soon as the recall was announced, a Simply Thick LLC press release (which was reviewed and approved by the FDA prior to its release)went on June 4th over PR Newswire, which instantly populates thousands of websites and all major search engines (including Google) with the text.

That press release is available here: http://www.prnewswire.com/news-releases/simply-thick-llc-announces-the-voluntary-recall-of-products-manufactured-by-thermo-pac-llc-at-their-stone-mountain-ga-food-processing-plant-123163898.html. The FDA also posted the release to their web site which triggers an email that goes to virtually all the healthcare facilities across the country.

2. All distributors of Simply Thick were contacted as soon as possible by Simply Thick sales reps and/or directly by Simply Thick.

3. Simply Thick LLC developed a list of over ten thousand people or places it has shipped to during the period of time affected by the recall. Although those who last purchased in June 2009 likely did not get any product produced within the window of the recall and are unlikely to have any product left, Simply Thick still included those purchasers in its notifications.

A . This list was sorted by date of last (most recent) order because it is most likely that purchasers who have ordered most recently are most like to still have any product subject to the voluntary recall.

B. Simply Thick has been constantly contacting customers on that list in groups from most recent purchasers back in time and is using the following process:

i. First we send an email to reported email addresses;

ii. Then we fax to reported fax numbers;

iii. Then we telephone to reported phone numbers;

iv. In addition to all of the above, everyone on the list is being mailed a letter to reported mail addresses regarding the voluntary recall.”

My son has been on this for 2 years, and it is provided by his insurance. I can not afford this what do I do?

I would contact the company for help:

“Consumers with questions may contact the company at its toll free number 1-800-205-7115 24 hours a day, or by email at latestinfo@simplythick.com.”

or fill in the SimplyThick Recall Service Request form, although I’m not sure how long the process takes to get new SimplyThick that isn’t in the recall.

Dr. Iannelli,

My son had been seizure free for over 4 years. Recently, he began having numerous (10 to 20 an hour) absence seizures again. His doctors and I have been unable to figure out what lowered his seizure threshold.

Having just read of this recall, I immediately checked his supply of Simply Thick, only to find that his last shipment was part of the recalled lot — and that he had consumed 96 of the 100 packets. The seizures began 2 to 3 days after he began the lot in question.

What is the likelihood that there is a connection? I fully understand that there has been no confirmation of contamination, but is it possible? How should I go about finding answers?

“What is the likelihood that there is a connection? I fully understand that there has been no confirmation of contamination, but is it possible? How should I go about finding answers?”

You should likely report your child’s reaction to MedWatch (The FDA Safety Information and Adverse Event Reporting Program).

If you are seeing a pediatric neurologist, you might ask how unusual it is for a child who has been seizure free for 4 years to start having seizures again. Is it extremely rare, something they see fairly often, or something they see from time to time?

How long does a baby need to be on the simply thick in order to have any complications due to the recall? My pharmacist said that it especially caused necrotizing of the small intestine in premature babies which is what my daughter is, and she was on the product for a short period of time. When I contacted the hospital she was staying at they said they had not heard of the recall although they were the ones who had put her on the simply thick due to the fact she aspirates when she feeds on her formula. I’m wondering now if this could have any link to the problems that had gotten worst since she was on this product with her stomach and the fact that they now would like to do two surgeries on my four month old baby.

“How long does a baby need to be on the simply thick in order to have any complications due to the recall?”

At this time, there are two separate issues out there about SimplyThick. There is the FDA warning that SimplyThick should not be given ‘to infants born before 37 weeks,’ including those sent home within the past 30 days. That warning is related to a possible risk of NEC (necrotizing enterocolitis) in babies fed breast milk or formula mixed with SimplyThick for varying amounts of time. Although the FDA reports 15 cases of NEC and two deaths, it is important to remember that it is still not known if SimplyThick is the cause.

The SimplyThick recall is a “result of the company’s failure to ensure that harmful bacteria of possible public health significance were destroyed in the manufacturing process at that manufacturing plant” because they “failed to file with the FDA a scheduled process designed to ensure that vegetative cells (harmful bacteria) of possible public health significance are destroyed during the manufacturing process.”

The FDA is still investigating the possible link between SimplyThick and the cases of NEC and the recall.

If your baby was on SimplyThick and got worse, you might ask your pediatrician about it and report it to MedWatch (The FDA Safety Information and Adverse Event Reporting Program).

I have a now 7 month old full-term baby with reflux so severe that she has been on thickened formula (at first to prevent aspiration and then continued to weigh her formula down in her stomach to assist with sustaining sufficient weight gain) since two weeks old. Since two weeks of age, we have been in a constant battle with digestive issues (reflux, poor motility, gas/bloating, and major constipation), and I am wondering if it is possible that simply thick could have exacerbated some of her issues? I know that they do not recommend use on preemies, but could there be issue with older full-term babies being given a steady diet of thickener?

“I know that they do not recommend use on preemies, but could there be issue with older full-term babies being given a steady diet of thickener?”

They haven’t reported any specific problems associated with the recall. If you have a specific concern, you should report it to Medwatch and talk to your pediatrician and/or pediatric GI doctor about it.

It is important to keep in mind that it can be difficult to treat children with severe reflux. I have had many children who improved remarkably after starting SimplyThick, after months of losing weight and be very fussy, when nothing else seemed to work.

A lot of attorneys are jumping on the Simply Thick recall bandwagon: http://www.pritzkerlaw.com/Defective_Medical_Devices/simply-thick-recall.html

My Daughter, born 2 months early, April 1st 2011 was on Simply thick, pudding consistency (so a triple dose) mixed with breast milk while in the NICU weeks before the recall. She was only taken off it, because she went septic, and had suspected late onset NEC ( she was 37.5 weeks gest) Taken off all feeds, put on many antibiotics and is still dealing with calcification of the kidneys, and thickening of the bowel . How do I go about finding out which batch she was getting at the hospital? Also, we are in Canada and there as not been a recall, just an advisory. How do I get my daughters case registered as a “possible” at the very least?

You could use the Med Effect Canada adverse reaction reporting system to report the possible reaction. And maybe report it to the company too.

I’m not sure how you could find out the batch or lot numbers, but the hospital is likely where to start. Even if it isn’t a part of her actual medical records, they might know which lots they were using at the time.

The possible association with NEC wasn’t necessarily linked with the recalled batches though.

I do hope she gets better soon.