News 04/06/1995
Don McLearn
(301) 827-6242
The Food and Drug Administration and Abbott Laboratories are
advising consumers against using counterfeit-labeled Similac with
iron "Ready to Feed" liquid formula in 8 oz. plastic cans with a
fictitious code number OCT96 L5 SI 89635. This product has been
illegally distributed with a counterfeit label and a fictitious
code number and expiration date and may be out of date.
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 Outdated products could have physical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
purchased 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.
####