McNeil Consumer Healthcare Announces Voluntary Recall of Certain OTC Infants’ and Children’s Products
FOR IMMEDIATE RELEASE - April 30, 2010 – Fort Washington, PA. McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., in consultation with the U.S. Food and Drug Administration (FDA), is voluntarily recalling all lots that have not yet expired of certain over-the-counter (OTC) Children’s and Infants’ liquid products manufactured in the United States and distributed in the United States, Canada, Dominican Republic, Dubai (UAE), Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago, and Kuwait. (SEE RECALLED PRODUCT LIST BELOW).
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.
The company is conducting a comprehensive quality assessment across its manufacturing operations and has identified corrective actions that will be implemented before new manufacturing is initiated at the plant where the recalled products were made.
Consumers can contact the company at 1-888-222-6036 and also at www.mcneilproductrecall.com1. Parents and caregivers who are not sure about alternative pediatric health treatment options should talk to their doctor or pharmacist and are reminded to never give drug products to infants and children that are not intended for those age groups as this could result in serious harm
For additional information, including affected NDC numbers, consumers should visit our website www.mcneilproductrecall.com or call 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/medwatch2.|
McNeil Consumer Healthcare, Division of McNeil-PPC, Inc. markets a broad range of well-known OTC products.
PRODUCTS NDC Number
TYLENOL® INFANTS’ DROPS:
CONCENTRATED TYLENOL® INFANTS’ DROPS 1 OZ. GRAPE FLAVOR 50580-144-01
CONCENTRATED TYLENOL® INFANTS’ DROPS 0.5 OZ. GRAPE FLAVOR* 50580-144-15
CONCENTRATED TYLENOL® INFANTS’ DROPS 1 OZ. CHERRY DYE FREE 50580-167-01
CONCENTRATED TYLENOL® INFANTS’ DROPS 0.5 OZ. CHERRY FLAVOR 50580-143-15
CONCENTRATED TYLENOL® INFANTS’ DROPS 1 OZ. CHERRY FLAVOR 50580-143-30
CONCENTRATED TYLENOL® INFANTS’ DROPS 0.5 OZ. GRAPE - HOSPITAL 50580-144-18
CONCENTRATED TYLENOL® INFANTS’ DROPS 0.25 OZ. GRAPE - SAMPLE 50580-144-40
CHILDREN’S TYLENOL® SUSPENSIONS:
CHILDREN’S TYLENOL® SUSPENSION 2 OZ. CHERRY BLAST FLAVOR 50580-123-02
CHILDREN’S TYLENOL® SUSPENSION 4 OZ. CHERRY BLAST FLAVOR 50580-123-04
CHILDREN’S TYLENOL® DYE-FREE SUSPENSION 4 OZ. CHERRY FLAVOR 50580-166-04
CHILDREN’S TYLENOL® SUSPENSION 4 OZ. GRAPE SPLASH 50580-296-04
CHILDREN’S TYLENOL® SUSPENSION 4 OZ. BUBBLEGUM FLAVOR 50580-407-04
CHILDREN’S TYLENOL® SUSPENSION 4 OZ. VERY BERRY STRAWBERRY FLAVOR 50580-493-04
CHILDREN’S TYLENOL® SUSPENSION 1 OZ. CHERRY BLAST FLAVOR – SAMPLE 50580-123-01
CHILDREN’S TYLENOL® SUSPENSION 4 OZ. CHERRY BLAST FLAVOR – HOSPITAL 50580-123-03
CHILDREN’S TYLENOL® PLUS SUSPENSIONS:
CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. COUGH & SORE THROAT CHERRY FLAVOR 50580-247-04
CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. COUGH & RUNNY NOSE CHERRY FLAVOR 50580-249-04
CHILDREN’S TYLENOL® PLUS DYE-FREE SUSPENSION 4 OZ. COLD & STUFFY NOSE GRAPE FLAVOR 50580-253-04
CHILDREN’S TYLENOL® PLUS DYE-FREE SUSPENSION 4 OZ. COLD & COUGH GRAPE FLAVOR 50580-254-04
CHILDREN’S TYLENOL® PLUS DYE-FREE SUSPENSION 4 OZ. MULTI-SYMPTOM COLD GRAPE FLAVOR 50580-255-04
CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. FLU BUBBLEGUM FLAVOR 50580-386-04
CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. COLD GRAPE FLAVOR 50580-387-04
CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. COLD & ALLERGY BUBBLEGUM FLAVOR 50580-390-04
CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. MULTI-SYMPTOM COLD GRAPE FLAVOR 50580-391-04
MOTRIN® INFANTS’ DROPS:
CONCENTRATED MOTRIN® INFANTS’ DROPS 1 OZ. BERRY DYE FREE 50580-198-01
CONCENTRATED MOTRIN® INFANTS’ DROPS 0.5 OZ. BERRY DYE FREE 50580-198-15
CONCENTRATED MOTRIN® INFANTS’ DROPS 0.5 OZ. BERRY FLAVOR* 50580-100-15
CHILDREN’S MOTRIN® SUSPENSIONS:
CHILDREN’S MOTRIN® SUSPENSION 4 OZ. BERRY DYE FREE 50580-184-04
CHILDREN’S MOTRIN® SUSPENSION 2 OZ. BERRY FLAVOR 50580-601-02
CHILDREN’S MOTRIN® SUSPENSION 4 OZ. BERRY FLAVOR 50580-601-04
CHILDREN’S MOTRIN® SUSPENSION 4 OZ. TROPICAL PUNCH FLAVOR 50580-215-04
CHILDREN’S MOTRIN® SUSPENSION 4 OZ. GRAPE FLAVOR 50580-603-04
CHILDREN’S MOTRIN® SUSPENSION 4 OZ. BUBBLEGUM FLAVOR 50580-604-04
CHILDREN’S MOTRIN® SUSPENSION 1 OZ. GRAPE SAMPLE 50580-603-01
CHILDREN’S MOTRIN® SUSPENSION 1 OZ. BUBBLEGUM SAMPLE 50580-604-01
CHILDREN’S MOTRIN® SUSPENSION 1 OZ. BERRY SAMPLE 50580-601-01
CHILDREN’S MOTRIN® SUSPENSION 4 OZ. BERRY HOSPITAL 50580-601-50
CHILDREN’S MOTRIN® SUSPENSION 4 OZ. COLD BERRY FLAVOR 50580-902-04
CHILDREN’S ZYRTEC® LIQUIDS IN BOTTLES:
CHILDREN’S ZYRTEC® 4 OZ. BUBBLEGUM SYRUP 50580-721-04
CHILDREN’S ZYRTEC® DYE FREE 4 OZ. GRAPE SYRUP 50580-730-04
CHILDREN’S ZYRTEC® SUGAR-FREE DYE-FREE 0.5 OZ. GRAPE 50580-730-15
CHILDREN’S ZYRTEC® SUGAR-FREE DYE-FREE 0.5 OZ. BUBBLEGUM 50580-721-15
CHILDREN’S ZYRTEC® SUGAR-FREE DYE-FREE 2 X 4 OZ. BUBBLEGUM LIQUID 50580-721-08
CHILDREN'S BENADRYL® ALLERGY LIQUIDS IN BOTTLES:
CHILDREN'S BENADRYL® ALLERGY 4 OZ. BUBBLEGUM FLAVORED LIQUID 50580-535-04
* CONCENTRATED TYLENOL® INFANTS’ DROPS 0.5 OZ. GRAPE FLAVOR is also included in JOHNSON'S ® Baby Relief Kit.
*CONCENTRATED MOTRIN® INFANTS’ DROPS 0.5 OZ. BERRY FLAVOR is also included in JOHNSON'S ® Baby Relief Kit
Thursday, May 6, 2010
Saturday, May 1, 2010
Sunday, April 25, 2010
Team Cyclone
Here is a video of Team Cyclone (Brody plus 2 others from his karate school) performing at the Capitol City Open Karate Tournament held in DeForest earlier this month. Unfortunately they were disqualified when one of the team members dropped his weapon at the very end of the routine...but they looked awesome!
Thursday, April 22, 2010
The Egg Challenge!
A couple of days ago Brody underwent some allergy testing with hopes of an egg challenge! His egg RAST numbers have been dropping by about half for the past several years. He started somewhere in the 60s I believe, but as of last RAST (June 2009) he was at 8.24. I didn't really expect him to pass raw egg quite yet,however, a recent study has shown that 70% of people with egg allergy can safely eat "baked-in" egg (350 degrees for at least 30 minutes) as this will break down the egg protein enough so that the body doesn't recognize it the same way.
So we started with the skin prick test (SPT) to raw egg. Actually, Dr. G also had us bring in some boiled milk to do a skin test with that too because some kids can apparently tolerate fully heated milk or baked-in milk just like the baked-in egg. They did the boiled milk and raw egg SPT at the same time and his skin bubbled immediately from the milk. In fact the nurse made the comment "whoa, and we still have 14 minutes on the timer before we measure it!" Then the raw egg wheal soon caught up to it. In fact at this point Dr. G wasn't even sure if he wanted to go ahead with the baked-in egg challenge. Brody was obviously feeling very defeated. You could just tell by his body language. One minute he had been so excited to get on with the test, and then after seeing how his skin reacted he was extremely sad looking. The doctor finally decided to take a small piece of the bread I had made and mix with water to make a "slurry" that they could use to do a SPT with to see how his skin would react to that. Luckily it only created a very small bump on his arm, so it was decided to go ahead with the challenge. He was a bit hesitant to take that first bite, but he loved the cinnamon bread I had made so it made the rest of the challenge go that much more smoothly. Good thing I didn't take the hockey puck blueberry muffins I had initially made! :) After 4 hours, Dr. G finally declared that Brody officially passed the "baked-in" egg challenge!!
I'm so happy and relieved the challenge is over! It definitely feels weird to feed him things with egg in them but also know that he will still have a severe reaction to egg that isn't baked long enough! I have quite a list of things I want to make now (brownies, angel food cake, lemon bars, etc...still dairy-free, but full of egg!), but I have to keep reminding myself that we need to start out slow and keep an eye out for any subtle reactions his body might show.
Dr. G also told us that because Brody had such a strong skin reaction to the boiled milk, that he is most likely one of those individuals who will never lose his milk allergy. I've always assumed this, but it's sad to actually hear it from the doctor. :( But on the bright side, after waiting 10 years, it sure is nice to at least have a little bit of good news regarding the food allergies!

This is a picture I took during the SPT. This is actually after the welts had started to diminish a little bit. In fact, the morning after the test he still had a small hive where the milk SPT had been placed!
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So we started with the skin prick test (SPT) to raw egg. Actually, Dr. G also had us bring in some boiled milk to do a skin test with that too because some kids can apparently tolerate fully heated milk or baked-in milk just like the baked-in egg. They did the boiled milk and raw egg SPT at the same time and his skin bubbled immediately from the milk. In fact the nurse made the comment "whoa, and we still have 14 minutes on the timer before we measure it!" Then the raw egg wheal soon caught up to it. In fact at this point Dr. G wasn't even sure if he wanted to go ahead with the baked-in egg challenge. Brody was obviously feeling very defeated. You could just tell by his body language. One minute he had been so excited to get on with the test, and then after seeing how his skin reacted he was extremely sad looking. The doctor finally decided to take a small piece of the bread I had made and mix with water to make a "slurry" that they could use to do a SPT with to see how his skin would react to that. Luckily it only created a very small bump on his arm, so it was decided to go ahead with the challenge. He was a bit hesitant to take that first bite, but he loved the cinnamon bread I had made so it made the rest of the challenge go that much more smoothly. Good thing I didn't take the hockey puck blueberry muffins I had initially made! :) After 4 hours, Dr. G finally declared that Brody officially passed the "baked-in" egg challenge!!
I'm so happy and relieved the challenge is over! It definitely feels weird to feed him things with egg in them but also know that he will still have a severe reaction to egg that isn't baked long enough! I have quite a list of things I want to make now (brownies, angel food cake, lemon bars, etc...still dairy-free, but full of egg!), but I have to keep reminding myself that we need to start out slow and keep an eye out for any subtle reactions his body might show.
Dr. G also told us that because Brody had such a strong skin reaction to the boiled milk, that he is most likely one of those individuals who will never lose his milk allergy. I've always assumed this, but it's sad to actually hear it from the doctor. :( But on the bright side, after waiting 10 years, it sure is nice to at least have a little bit of good news regarding the food allergies!

This is a picture I took during the SPT. This is actually after the welts had started to diminish a little bit. In fact, the morning after the test he still had a small hive where the milk SPT had been placed!
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Monday, April 12, 2010
Allergic Living's 5th Anniversary Contest
Test your allergy knowledge by taking the Allergic Living Quiz. You could win one of 4 copies of Cybele Pascal's The Allergen-Free Baker's Handbook!
**Contest closes Friday, May 7, 2010**
http://www.allergicliving.com/contest/
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**Contest closes Friday, May 7, 2010**
http://www.allergicliving.com/contest/
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Friday, March 12, 2010
Hippity, Hoppity, Easter's on its way!
If the Easter Bunny is looking for ideas about what treats would be safe to bring your food allergic child this Easter, tell him (or her) to hop on over to the Premium Chocolatiers website! This company specializes in milk-free, egg-free, nut-free, and gluten-free gourmet chocolates. These delicious goodies are hand crafted using a signature blend of roasted cocoa beans along with the finest ingredients!
http://www.premiumchocolatiers.com/easter-fun-c-21.html
Happy Easter to all!
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http://www.premiumchocolatiers.com/easter-fun-c-21.html
Happy Easter to all!
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Friday, February 12, 2010
Valentine's Day Treats

Valentine’s Day is just a few days away, and what better way to let your friends and family know how much you love them than to make allergy-friendly Valentine treats! Whether you make heart shaped pancakes for breakfast or just frost sugar cookies with pink icing, your little ones will be excited and feel extra special! But if you’re looking for some new ideas, maybe you’d like to give one of these recipes a try…
Lemony Love Potion
12-ounce can of pink lemonade concentrate
1 cup raspberry sorbet (I use Whole Fruit brand, available at Woodman’s)
12 ounces lemon/lime soda
In a pitcher, prepare the lemonade concentrate with recommended amount of water. In a separate pitcher, combine the sorbet, soda, and 1 cup of the lemonade. Stir, serve, and enjoy!
Easy Oreo Truffles
1 (16 ounce) package Oreo cookies
1 (8 ounce) container Tofutti soy cream cheese
1 package Enjoy Life chocolate chips
Crush cookies in a food processor or resealable plastic bag using a rolling pin. Place in a medium bowl. Add soy cream cheese and mix until well blended. Roll cookie mixture into balls, about 1 inch in diameter. Place balls in refrigerator or freezer for about an hour. Melt the chocolate chips in a double boiler. Dip the balls in the chocolate and place on a wax paper covered baking sheet. Decorate with sprinkles or colored sugar if desired. Refrigerate until firm. Store leftover truffles, covered, in refrigerator.
Variation: Use Golden Oreos in place of the chocolate Oreos and add a couple drops of red food coloring to the cookie/soy cream cheese mixture to give the truffles a nice pink color for Valentine’s Day when biting into them!
And of course you can never go wrong with…
Chocolate Covered Strawberries
1 package Enjoy Life chocolate chips
2 Tbsp shortening (optional)
1 pound fresh strawberries with leaves
In a double boiler, melt the chocolate chips and shortening, stirring occasionally until smooth. Carefully dip the strawberries into the chocolate mixture and place on wax paper to cool. Refrigerate until the chocolate is set.
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