The relabeled formula has been found in retail stores in Alaska, Arizona, California, Connecticut, Florida, Louisiana, Maryland, Massachusetts, Michigan, Nevada, New Jersey, New York, Pennsylvania, Rhode Island, Texas and Washington. The counterfeit-labeled product may be found also in other parts of the country.
The misbranded "Ready to Feed" products are in 8 oz. plastic cans with metal lids and have been sold in six-packs. The cans can be identified by the false lot number and the counterfeit labels which are made of paper. Genuine Similac labels are made of plastic and have a silver foil backing.
Because of the removal of original code number and the unknown production date of the relabeled cans, FDA and the manufacturer have no assurance of the quality and integrity of the product. Outdated products could have physical characteristics such as separation of constituents, lumpiness or grainy consistency.
A few of the illegally relabeled Similac cans also have been found to contain Isomil, a soy-based formula by the same manufacturer as Similac. Consumption of Isomil instead of Similac does not pose a health risk.
To date no adverse event attributable to this counterfeit-labeled infant formula has been reported to FDA. At this time, FDA has no information indicating that the misbranded product is hazardous.
Consumers are encouraged to return the counterfeit-labeled Similac with iron "Ready to Feed" infant formula in 8 oz. cans with lot number OCT96 L5 SI 89635 to the store where they purchase it.
Ross Products, a division of Abbott Laboratories in Abbott Park, Ill., which manufactures both Similac and Isomil, is cooperating with FDA's investigation of the incident.
For further information, consumers may call Ross Products at 1-800-841-7001.
Don McLearn
(301) 827-6242
Hypertext updated by dms 2002-MAY-29