"Manufacturing Deficiencies" Lead to Recall of Some McNeil Products

A voluntary recall of certain children's over-the-counter liquid medicines has been issued by the McNeil Consumer Healthcare unit of Johnson & Johnson. These products include Tylenol Infants' Drops, Children's Tylenol Suspensions, Infants' Motrin Drops, Children's Zyrtec Liquid in bottles, and Children's Benadryl Allergy liquids in bottles. "Manufacturing deficiencies" may affect affect the potency (strength), purity, or quality of the products. Parents are urged to check the products they have at home and stop using them if the lot number matches one on the list of recalled medicines. According to the company, some products may actually have too much of the active ingredient in the product, others may have tiny particles or inactive ingredients that fail testing requirements. Even though it is unlikely that a serious medical problem will occur as the result of giving the recalled medicine, it is not recommended that these products be given to children.

Be sure to talk to the pharmacist or doctor about alternative options to these recalled medicines for children to treat pain, fever, or allergies. For additional information, please visit McNeil's website or call 1-888-222-6036 (8 am - 10 pm ET on Monday-Friday and 9 am - 5 pm ET on Saturday and Sunday). Any suspected reactions may be reported to the FDA's MedWatch program on the FDA's website.

By the way, generic products are not affected by the recall. They are made by other companies that have been approved by the FDA and distributed by the pharmacy/drug store. Generic drugs have been tested and meet the standards of the FDA and work just as well as the brand name equivalents. If you are interested in knowing if a generic version is available, you can check the Orange Book, which is an official list of approved generic drugs.

Recall of Certain Lots of Infants' and Children's TYLENOL Products

Did you buy TYLENOL brand infant's or children's products between April 2008 and June 2008? Certain lots are being recalled by the company, McNeil, because when they examined the bulk raw material, they found that one of the inactive ingredients did not meet internal testing requirements. A type of gram-negative bacteria, B. cepacia, was found and isolated in this portion of raw material. NOTE: no bacteria were detected in any of the finished products, but, as a precaution, the company has volunteered to recall all product made when that particular batch of raw material was present in the factory. Again, no need to panic because the bottle you have at home does not contain bacteria and it was not made from that specific batch of raw material. No side effects have been reported to the company or FDA from these products. Also, one cannot get an infection from this bacteria by taking the medicine. If your child has an underlying lung disease, cystic fibrosis, or a weaker immune system, the bacteria could cause adverse effects. To check to see if the bottle you have at home is being recalled, look for the lot number at the bottom of the box that came with the bottle, or on the sticker that surrounds the bottle. Below is the complete list of recalled lots. If you determine that you have the affected product, please call McNeil's Customer Care Center at 1-800-962-5357 to be sent a coupon for a new bottle. Please contact your child's doctor if you have specific concerns or if you have recently given your child Tylenol purchased during April and June 2008.

Recalled Products - Full List

Lot #	Product Description
SBM041, SBM067, SCM037, SDM027, SEM109	Children's Tylenol Plus Cold MS Suspension 4 oz. Grape
SBM042, SCM015, SCM036, SDM034	Children's Tylenol Suspension 4oz. Grape
SBM043, SBM044, SCM029	Children's Tylenol Suspension 4oz. Bubble Gum
SBM045, SCM011, SCM030, SDM035	Children's Tylenol Suspension 4oz. Strawberry
SBM064, SCM033, SDM020	Infant’s Tylenol Grape Suspension Drops 1/4oz.
SBM065, SCM005, SCM006, SDM032	Infant's Tylenol Suspension 1/2oz. Cherry
SBM066, SCM068	Children's Dye Free Suspension 4oz. Cherry
SBM068, SCM035, SCM070, SCM080, SDM005	Children's Tylenol Suspension 4oz. Cherry
SBM069, SBM070, SCM081, SDM006	Children's Tylenol Plus Cough & Runny Nose 4oz. Cherry
SCM012, SCM067, SDM007, SDM068	Infant's Tylenol Suspension Drops 1/2oz. Grape
SCM013, SCM014, SCM069	Children's Tylenol Plus Flu 4oz. Bubble Gum
SCM016, SFM024	Children's Tylenol Plus Cold Suspension 4oz. Grape
SCM017	Children's Tylenol Plus Cough/ST Suspension 4oz. Cherry
SCM082, SDM039, SDM040	Infant's Tylenol Suspension Drops 1oz. Grape
SCM083, SCM084, SDM008	Infant's Tylenol Dye Free Suspension 1oz. Cherry
SDM064	Children’s Tylenol Pediatric Suspension 1oz. Cherry
SDM038, SDM009	Infant's Tylenol Suspension Drops 1oz. Cherry
SDM033	Children's Tylenol Plus Cold/Allergy 4oz. Bubble Gum
SDM078	Infant's Tylenol Drops 1oz. Grape
SCM034	Infant’s Tylenol Grape Suspension Drops H/G 1/2oz.
SDM028	Children's Tylenol Suspension 4oz. Cherry, Hospital Govt.

Sticky situation

This is one of the few times when having a food allergy works in your favor - not getting salmonella! Since my husband has a known peanut allergy, we have never stocked food with peanuts or peanut-butter. Well, my daughter just recently tested negative for a peanut allergy using peanut butter from a major brand. She actually did well and liked it then, but she doesn't anymore. She says "it's too sticky." I'm glad I didn't buy a variety of snacks with peanut butter, because I probably would have to throw out a lot of food. I subscribe to updates from the FDA and CDC, and I have been getting a swarm of emails everyday about new recalls. Check if what you have is being recalled with this list. Read more about Salmonella here. You can even blog about the recall. My recommendation? Just throw it all out to be safe! It's not worth the diarrhea, fever, and and abdominal cramps, especially if your child has a weakened immune system.

Oh, and don't buy one of those cute little turtles you see in a little plastic container from the street vendors - they harbor salmonella, too!