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Possible Oxidation Prompts Infant Formula Recalled

Jan 1, 2008 | Parker Waichman LLP

The US Food and Drug Administration (FDA) just announced that Abbott is voluntarily issuing a worldwide recall of two lots of Calcilo XD Low-Calcium/Vitamin D-Free Infant Formula with Iron Powder in 14.1-Ounce (400g) cans.  The formula recall involves approximately 13,000 cans.

According to the FDA, two lots of recalled Calcilo XD® Low-Calcium/Vitamin D-Free Infant Formula with Iron powder were distributed in 14.1-ounce cans (400g).  Only the 14.1-ounce (400g) cans are involved in this action.  Calcilo XD® is a low-calcium and vitamin D-free infant formula created for the nutrition support of infants and children with hypercalcemia—high calcium in blood. Calcilo XD® is only available by special order.

Abbott is voluntarily recalling two lots of Calcilo XD® as small amounts of air may have entered the can, resulting in product oxidation.  A common sign of oxidation is an “off” aroma.  The problem is isolated to these two lots of Calcilo XD Powder in 14.1-ounce (400g) cans with stock code number 00378 and with lot numbers 39973RB or 47239RB6 printed on the bottom of the cans.  No other Calcilo XD powdered infant formulas are affected.

Consumption of highly oxidized foods can cause gastrointestinal (GI) symptoms such as nausea, vomiting, and diarrhea. If parents have questions or concerns they should contact a health care professional.

The two lots were distributed in the United States, Canada, Malaysia, Korea, and Bahrain, between June 6, 2006 and April 17, 2008. Consumers who purchased Calcilo XD® Low-Calcium/Vitamin D-Free Infant Formula with Iron powder from either of the two recalled lots should contact Abbott Nutrition at 1-800-638-6493.

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