June 6, 1999
Mead Johnson Recalls One Batch of ProSobee®
8-Ounce Ready-To-Use Infant Formula
EVANSVILLE, IN (SafetyAlerts) - Mead Johnson
Nutritionals, in keeping with its commitment to provide safe and healthy nutrition to
infants, is informing parents of a recent product labeling error.
As a precaution, the company is recalling one
batch (approximately 7,000 cases) of 8 ounce ready to use ProSobee® infant formula sold
in 4 pack fiberboard cartons. All other batches of 8 ounce ProSobee and all other
forms of ProSobee - powder, liquid concentrate and 32 ounce ready-to-use - are not
The batch in question, coded
1NOV99/PROSOB/AKN13, began shipping to stores late last year. One can in
the batch was found to be mislabeled as ProSobee when in fact it contained Vanilla
Sustacal® bearing the code 1MAY00/VSUST/AKN43H. There is the
possibility that a few additional cans may be mislabeled. Sustacal, an adult
nutritional supplement, contains milk and soy proteins.
The composition of Sustacal, the mislabeled
product, differs in caloric density and nutrient and water content from that of
ProSobee. Sustacal also looks, smells and tastes different than
ProSobee. For infants who are ill and at risk of dehydration, are highly
sensitive to milk proteins, or have galactosemia, use of the mislabeled product has the
potential to cause severe medical problems if consumed.
The Recalled ProSobee was distributed
nationwide through retail stores and pharmacies.
The recall was initiated after the Mead Johnson
Nutritionals Customer Resource Center received a telephone call from a parent who had
noted the physical and organoleptic (smell) differences between one can of ProSobee and
other cans used previously. After subsequent investigation, it was determined that
the can in question bore the embossed identification of another Mead Johnson product,
Vanilla Sustacal, a product formulated to meet the nutritional needs of an adult
consumer. The three other cans in the 4-pack carton were all correctly labeled
No illness related to this batch of ProSobee has
been reported to Mead Johnson. However, parents should check cans of 8 ounce
ready-to-use ProSobee for the above codes and these should be returned to Mead Johnson
Nutritionals. Consumers can call 1-888-587-7275 for return instructions
" As a company trusted by parents throughout
the world, we won't take chances with our products or our customers." said Dr. J.
Roberto, vice president, medical affairs, Mead Johnson Nutritionals. "We are
taking these extra precautionary measures to minimize any risks to infants in the
extremely unlikely event of exposure"
Parent with questions regarding the recall may
call the Mead Johnson Customer Resource Center at 1-888-587-7275