Abbott recalls nearly 5,000 bottles of infant formula due to mislabeled bottles

Formula does not contain as much iron as indicated on label

06/04/07

On May 29, 2007, Abbott Laboratories announced a nationwide recall of almost 5,000 bottles of its Similac Special Care Ready-to-Feed formula with iron for premature infants. The formula does not contain as much iron as indicated on the label.

The recalled product is sold in cartons of eight two-ounce plastic bottles through pharmacies at the direction of a health care professional. It is not usually available on retail store shelves. The recalled formula is used only for premature infants after they are discharged from the hospital and is not used in the hospital itself.

While no serious medical complaints have been reported, premature infants who are fed this formula for more than a month after discharge could develop anemia from insufficient iron intake.

The recall applies to products with stock code number 59582 and lot numbers 46815D5, 47847D5 or 52023D5 printed on the outside carton and case. The recall also applies to products with lot numbers 44427X8, 44427X81 or 50005X8 printed on the bottom of the bottles.

The three recalled lots of the formula were distributed in the United States between November 2006 and May 2007.

Parents with concerns about their baby’s health are urged to contact their baby’s doctor or health care professional.

For more information, consumers can contact Abbott’s Ross Products Division at 1-888-899-9182, and the company will replace the product free of charge.

Source: “Abbott Similac Special Care 24 Cal/fl. oz. Ready-to-Feed Premature Infant Formula with Iron,” Food and Drug Administration Medical Safety Alert, May 29, 2007; “Premature infant formula recalled,” Kansas City Star, May 25, 2007; “Abbott Announces Voluntary Nationwide Recall of Three Lots of Two-Ounce Bottles of Similac Special Care 24 Cal / fl. oz. Ready-to-Feed (RTF) Premature Infant Formula with Iron,” Abbott Laboratories press release, May 25, 2007.

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