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Posted November 4, 2002

Recall Of Selected Store Brand Infant Formula in U.S.

On November 1, 2002, Wyeth Nutrition, in consultation with the U.S. Food and Drug Administration (FDA), initiated a voluntary recall of all batches of store brand powdered milk and soy-based infant formula produced between July 12 and September 25, 2002 at the Company's Georgia, Vermont manufacturing facility. Low levels of Enterobacter sakazakii (E. sakazakii), a bacterium that is common in the environment, were detected in tests of retained samples manufactured at the facility during this period.

The nationally distributed powdered infant formula brands being recalled have an expiration date (use by) between 07 28 2005 and 09 28 2005 embossed on the bottom of the can. The brands being recalled include: Baby Basics, CVS, Home Best, Healthy Baby, Kozy Kids, Hill Country Fare or HEB, Little Ones, Parent's Choice, Safeway Select, and Walgreen's.

Consumers who have cans of infant formula with the expiration date between 07 28 2005 and 09 28 2005 can return the product to the place of purchase. Consumers can also call 1-888-526-5376 for information about this recall.

There have been no reports of illness associated with E. sakazakii infection as a result of ingestion of Wyeth infant formula. However, in recent years there have been reports in scientific literature identifying very rare cases of infections associated with this bacterium. Most reported cases have been in immunocompromised and/or premature infants. Although the incidence of illness from E. sakazakii is very low, it can result in a serious condition, especially for high risk infants.

In April 2002, the FDA wrote to health care providers advising them that high risk infants should always be fed with liquid formula, which is commercially sterile. All of the powdered infant formula affected by Wyeth's recall is marketed for healthy, full-term infants. Wyeth's liquid formula products are not affected. The recall does not affect products produced at any other Wyeth Nutrition manufacturing facility.