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NUTRICIA SOYALAC INFANT FORMULA CLASS I RECALL ABOUT 90% COMPLETE

This article was originally published in The Tan Sheet

Executive Summary

NUTRICIA SOYALAC INFANT FORMULA CLASS I RECALL ABOUT 90% COMPLETE following the detection of Salmonella in powdered forms of the product. Mt. Vernon, Ohio-based Nutricia initiated a recall of 116 cases of Soyalac powder (in 14-ounce cans) via a March 24 memorandum to its customers. The firm subsequently extended the recall on June 22 to include all Soyalac 14-ounce infant formula powders distributed in the U.S. and Canada that were processed at Maple Island, an independent food processing plant located in Wanamingo, Minn. Nutricia said that it is planning to send additional notifications by mid-August to customers who have not responded to the initial recall notices. The recall does not apply to liquid Soyalac products or to I-Soyalac infant formula, the company said. The Soyalac recall is one of several executed by companies whose products are dried and/or packaged by Maple Island. On June 29, FDA mandated the recall of all products dried or packaged at the facility since Nov. 4, 1992, the earliest date to which FDA sampling traced Salmonella contamination. In addition to Soyalac infant formula, Maple Island processes powdered products for 10 other companies and manufactures products for sale under its own labels. Other products processed at the facility that have been subject to recalls include medical foods, whole milk powder, nonfat dry milk, ice cream mixes and powdered nutritional supplements such as Sherwood Medical's Propac protein supplement and Sumacal carbohydrate supplement. Both Sherwood Medical products are distributed to medical suppliers, hospitals and nursing homes. In a June release, FDA noted that it had initiated an investigation of Maple Island after "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 FDA and company sampling identified contamination by a bacterial strain called Salmonella tennessee, Maple Island voluntarily "stopped its drying operations and undertook a major cleanup of the facility," according to FDA. Following additional sampling at Maple Island, the plant "shut down its operations" entirely, the agency said. No spray-dried products have been distributed from Maple Island since June 7. Among companies whose products were manufactured at the facility and are subject to recall are Burlingame, Calif.-based Dean Distributors, which markets MediBase, MediBase II and Cambridge very low-calorie meal replacement drinks. On July 7, Dean Distributors initiated a Class II recall of 42,734 cans of Cambridge products and 597 cans of MediBase products distributed in the U.S. because they "were manufactured under conditions in which they may have become contaminated by Salmonella," FDA's July 21 Enforcement Report states. Dean Distributors emphasized in a release, however, that "there have been no reports of any problems associated with patients using the MediBase meal replacement" products. The firm explained that "independent lab reports were conducted at the time of manufacturing which found no contamination whatsoever on the MediBase products," adding that FDA "has not found anything wrong with the MediBase meal replacement products." Dean Distributors characterized the MediBase recall as "a precautionary measure" following the contamination of Soyalac infant formula. Wyeth-Ayerst also recalled cans and sachets of its Enercal and Promil powdered nutritional supplements for infants and children that were processed at Maple Island. Wyeth-Ayerst initiated the Class I recall on July 1 to retrieve 1,096,992 units of Enercal and Promil from Taiwan, Malaysia, Singapore, the Dominican Republic, Hong Kong and Thailand, FDA's July 21 Enforcement Report says. None of the Maple Island-processed Wyeth-Ayerst products were distributed in the U.S. Cans of Ross Laboratories' Formance fortified nutritional powder for use by pregnant and lactating women also were recalled due to being processed at the Wanamingo facility (see Enforcement Report on p. 17). The Formance recall, initiated on June 28, applies to 10,978 850-gram cans (two batches) of Formance shipped to Hong Kong. Ross Labs' Similac infant formula also is manufactured at Maple Island; however, the recall did not extend to Similac because none of the powdered infant formula left the firm's warehouses. Ross emphasized that no Salmonella contamination has been detected in the Formance batches. FDA said it is continuing to identify companies whose products have been dried and/or packaged at Maple Island, and to date, is not aware of any illnesses caused in the U.S. by products under recall. In the July 9 issue of the Centers for Disease Control and Prevention's Morbidity and Mortality Weekly Report, CDC noted that three Soyalac-related cases of Salmonella tennessee infection have been identified -- two in Canada and one in Illinois. CDC observed that "the isolates of Salmonella tennessee that were identified from the three infants" are "atypical of salmonellae because most colonies ferment lactose and, therefore, may not be detected by clinical laboratories that use media or methods that identify salmonellae based on the absence of lactose fermentation." CDC concluded: that health care providers and public health departments should continue "routine reporting to the Salmonella surveillance system; that "all Salmonella serogroup C[1] (of which Salmonella tennessee is a member) isolates be serotyped"; and that "persons infected with Salmonella tennessee be questioned specifically about consumption of powdered milk products or infant formula."
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