Fri, Jan 15, 2010 (BabyCenter News) — McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson, has announced a recall of two types of children’s Tylenol.

This recall is part of a larger product recall that includes various over-the-counter drugs — including adult medications — made by McNeil.

The drugs are being recalled due to reports of an unusual, moldy, musty, mildew-like odor. In a small number of cases, the odor has been linked with symptoms like nausea, stomach pain, vomiting, or diarrhea.

The types of children’s Tylenol being recalled include:

* Children’s Tylenol Bubblegum Meltaway 30 count (NDC Code # 50580-519-30, UPC Code # 300450519306), lots AHA069 and SPA022
* Children’s Tylenol Grape Meltaway 30 count (NCD Code # 50580-518-30, UPC Code # 300450518309), lots AHA023 and AHA057

The lot numbers are printed on the side of the bottle label.

McNeil is recalling all product lots with any chance of being affected, even if they haven’t been the subject of any consumer complaints.

The company has determined that the odd smell is caused by trace amounts of a chemical called 2,4,6-tribromoanisole (TBA), which is a known breakdown product of a pesticide and flame retardant used to treat the wooden pallets that store and move the medicine bottles.

In addition to the recall, McNeil says it will stop shipment of all products that use materials transported on these wooden pallets and require all of its suppliers to discontinue using the pallets.

The recall comes after McNeil received a warning letter from the United States FDA. The agency criticized the company for failing to react quickly enough to consumer complaints.

(Editor’s note: BabyCenter is also owned by Johnson & Johnson.)

WebMD Medical Reference

Soy? Whole milk? Hypo-allergenic? Most large supermarkets contain a bewildering array of baby formula choices. Some infant formulas are iron fortified; others contain the fatty acids DHA and ARA. Some are based on soy or cow’s milk; others are made for babies with lactose intolerance. Some are even low in sodium.

How do you choose the right baby formula from this abundance? First, it helps to understand a few infant formula basics.

Baby Formula: 3 Forms to Choose From

Although breast milk offers newborns all the nutrition they need, not every mom can or chooses to breastfeed. And, moms who do breastfeed may find that supplementing with infant formula when baby gets older is a practical alternative if they go back to work or when Dad feeds baby.

Commercially prepared baby formulas are FDA-regulated to provide babies all the nutrients they need. They come in three main forms:

• Powders. The least expensive option, these are usually mixed with water – one scoop to two ounces of water.
• Liquid concentrates . Pricier than powders, these are generally diluted with an equal part of water.
• Ready-to-use baby formulas. Often the most expensive and convenient, ready-to-use formulas can be poured straight into baby’s bottle.

Formula Facts: What’s in It for Baby?

The three forms of formula — powders, concentrates, and ready-to-use – are based on different ingredients:

• Milk-based baby formulas

Made with cow’s milk, vegetable oils (for fat calories), vitamins, and minerals — and usually iron-fortified (as recommended by the American Academy of Pediatrics) — milk-based formulas are appropriate for healthy, full-term babies.

• Soy-based baby formulas

Made with soy protein, vegetable oils, corn syrup and/or sucrose (for carbohydrates), and sometimes iron, these formulas are good for babies with lactose intolerance who can’t take milk-based formulas, or those who have allergies to the whole protein in cow’s milk or are on a vegetarian-based diet. Soy infant formulas aren’t recommended for low-birth-weight or preterm babies.

• Specialty baby formulas

This is a big category, with infant formulas for low-birth-weight babies, low-sodium formulas for babies who need a restricted salt intake, and “predigested” protein formulas for babies who can’t tolerate or have allergies to the whole proteins in cow’s milk and milk-based formulas.

Infant formulas enriched with DHA and ARA omega fatty acids from algae have also found their way into the jam-packed baby formula aisle. These fatty acids appear to help baby’s brain and nerve development and improve vision.

The Right Formula for Your Baby

With all those choices, how can you figure out what’s best for your child?

Begin by asking your baby’s pediatrician for recommendations. Talk to friends and family about what they use and why. You may also have a chance to sample a wide range of baby formulas, as moms are often sent home from the hospital with free baby formula or coupons.

No matter which baby formula you start with, it helps to know that all formulas made in the United States meet strict FDA guidelines for nutrition, so your infant will probably do just fine on any of them. Whichever baby formula you choose, however, be sure to check its expiration date and don’t buy damaged cans or bottles.

The FDA is warning General Mills about health claims on the Cheerios label, but General Mills says its science is strong.

In a warning letter sent to General Mills, the FDA notes Cheerios is “misbranded” in a way that makes the cereal sound like a drug to prevent, mitigate, and treat high cholesterol and heart disease.

As evidence, the FDA points to language on the Cheerios label that includes this statement: “Did you know that in just 6 weeks Cheerios can reduce bad cholesterol by an average of 4 percent? Cheerios is … clinically proven to lower cholesterol. A clinical study showed that eating two 1.5 cup servings daily of Cheerios cereal reduced bad cholesterol when eaten as part of a diet low in saturated fat and cholesterol.”

The FDA does allow a health claim linking soluble fiber from whole-grain oats with a lower risk of coronary heart disease, and also to include — as part of that statement — a note about lowering total and LDL cholesterol levels.

But according to the FDA, the Cheerios label inappropriately separates the heart disease and cholesterol claims.

The FDA also takes issue with a General Mills’ web site mentioned on the Cheerios label that uses language that doesn’t comply with approved health claims.

For instance, the approved health claim about heart disease is supposed to mention fiber, fruits, vegetables, and a low-fat diet — not just whole-grain foods. And the FDA warned General Mills about another statement on that same web site that linked whole grains, as part of a low-fat diet, to reduced risk of stomach and colon cancers. That’s not an approved health claim.

The FDA’s warning letter, which is dated May 5, 2009, and is posted on the FDA’s web site, gives General Mills 15 days to correct the problems.

In response, General Mills has posted a statement on its web site.

General Mills states that “Cheerios’ soluble fiber health claim has been FDA-approved for 12 years, and Cheerios’ ‘lower your cholesterol 4% in 6 weeks’ message has been featured on the box for more than two years. The science is not in question. The scientific body of evidence supporting the heart health claim was the basis for FDA’s approval of the heart health claim, and the clinical study supporting Cheerios’ cholesterol-lowering benefit is very strong.”

General Mills states that the FDA “is interested in how the Cheerios cholesterol-lowering information is presented on the Cheerios package and web site.” The company says it looks forward to discussing and resolving the matter with the FDA.

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