 |
 |
 |
|
 |
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
Contact:
Consumer Hotline
(800) 638-6493
FOR IMMEDIATE RELEASE -- May 30, 2008 -- Abbott today announced a voluntary worldwide recall of two lots of Calcilo XD® Low-Calcium/Vitamin D-Free Infant Formula with Iron powder in 14.1-ounce cans (400g). Only 14.1-ounce (400g) cans are involved in this action. Calcilo XD® is a low-calcium and vitamin D-free infant formula that is specifically designed for the nutrition support of infants and children with hypercalcemia (high calcium in blood). It is only available by special order.
Abbott is voluntarily recalling two lots of product because 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.
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 recall is limited to Calcilo XD 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.
The two lots were distributed in the United States, Canada, Malaysia, Korea and Bahrain, between 06/06/06 and 04/17/08. Consumers who purchased Calcilo XD® Low-Calcium/Vitamin D-Free Infant Formula with Iron powder from either of the two lots mentioned above should contact Abbott Nutrition at 1-800-638-6493.
Abbott is working with its distribution partners and the U.S. Food and Drug Administration to execute this recall.
#
