FDA Announces recall of Products from Maple Island Inc

NEWS 06/29/1993 FDA Announces recall of Products from Maple Island Inc



P93-29                               Food and Drug Administration
FOR IMMEDIATE RELEASE                Chris Lecos (202) 205-4144


     The Food and Drug Administration today announced the recall of
products dried and/or packaged at Maple Island Inc., a food
processing plant at Wanamingo, Minn., because of Salmonella
contamination. 
     Consumers who have purchased Soyalac Powder infant formula
should return it to the point of purchase. Institutions and
individuals who have purchased powdered Sumacal, a medical food
supplement, and Propac, a powdered protein supplement, should also
return these products to the point of purchase, or call 1-800-325-
7472 for instructions.   
     Maple Island Inc. processes dry soy- and milk-based infant
formulas and other powdered products for 11 companies as well as
for sale under its own labels. Recalls requested by FDA included
powdered infant formulas, medical foods, whole milk powder, nonfat
dry milk, ice cream mixes, powdered drink for meal replacement and
a powdered supplement for use by lactating or pregnant women. 
     All of the products under recall have been spray dried and/or
packaged in the Wanamingo plant since November 4, 1992, the
earliest date to which FDA sampling traced the Salmonella   
contamination.
     FDA initiated investigation of Maple Island Inc. after 
                             -MORE-     

                                   Page 2, P93-29, Formula Recall
Canadian authorities reported that two infants who had consumed
Soyalac formula spray-dried at the Wanamingo plant had developed
salmonellosis, a disease that can be life-threatening for very
young children. 
     After initial FDA and company sampling identified
contamination by a strain of bacteria called Salmonella tennessee,
the plant voluntarily stopped its drying operations and undertook
a major cleanup of the facility. Following additional FDA sampling,
Maple Island Inc. shut down its packing operations and initiated
its recalls.
     FDA has focused its efforts on infant formulas and medical
foods because infants and the elderly are most vulnerable to
salmonellosis. In addition to Maple Island Inc., FDA informed of
the recall notice the following firms whose products had been
processed at the Wanamingo plant:
     -- Nutricia Inc., Mt. Vernon, Ohio, which distributes Soyalac
Powder infant formula.  The company previously announced two
separate recalls of some of its powdered Soyalac products in 14 oz.
cans and is now recalling all lots of Soyalac powder in 14 oz.
cans. 
     -- Sherwood Medical Co., St. Louis, Mo., which sells Sumacal,
a medical food supplement distributed to medical suppliers,
hospitals and nursing homes, and Propac, a protein supplement. The
company is recalling two lots of Sumacal 14 oz. cans, lot nos.
964934 and 964935, and one lot of Propac, no. 965064 in 12.3 oz.
cans.                         -MORE-
                                
                                    Page 3, P93-29, Formula Recall
     -- Ross Laboratories, Columbus, Ohio, which distributes
Similac Infant Formula and Formance, a nutritional supplement for
pregnant or lactating women. The company said no powdered Similac
formula from the plant left its warehouses, and therefore there is
no need for consumers to return it to the point of purchase.
Formance is only sold abroad.
     -- Wyeth Nutritional Inc., Georgia, Vt., which sells Promil,
a weaning formula; Enercal, a diet beverage; and Enercal Plus,
which can be used for convalescing patients. All three products are
only sold abroad.
     All foreign distributors of these products are being advised
of this recall.
     FDA has not yet been informed how much of the Wanamingo
plant's production that might be contaminated has reached the
retail sector. 
     The agency is continuing to identify companies whose products
have been dried and/or packaged at the plant since November. 
     FDA is not aware of any illnesses caused in the United States 
by the products under recall. 
     FDA is one of eight agencies of the Public Health Service.
                              ####