Salmonella recovered from King Nut peanut butter by MDA lab found to be a genetic match to cases in national Salmonella outbreak

The Minnesota Departments of Agriculture and Health announced January 12 that laboratory analyses have confirmed a genetic match between the strains of Salmonella bacteria found in a container of King Nut brand creamy peanut butter and the strains of bacteria associated with 30 illnesses in Minnesota and nearly 400 illnesses around the country.

MDA lab tests conducted last week discovered Salmonella bacteria in a 5-pound package of King Nut peanut butter collected from a long-term care facility associated with one of the reported illnesses. The Minnesota Department of Agriculture (MDA) and the Minnesota Department of Health (MDH) issued a product advisory on Friday alerting institutions that may have received the product. MDA and MDH scientists performed additional testing this weekend to verify the connection between the contaminated product and the illnesses.

State officials initially discovered the contaminated product through product testing conducted after MDH epidemiological evidence and an investigation by MDA’s Rapid Response Team implicated King Nut creamy peanut butter as a likely source of Salmonella infections in Minnesota residents. In the product advisory issued Friday, state officials urged establishments who may have the product on hand to avoid serving it, pending further instructions as the investigation progresses.

Eating food contaminated with Salmonella can result in abdominal cramping, diarrhea, and fever. Anyone who believes they may have become ill as a result of eating this product or foods made with this product should contact their health care provider.

King Nut peanut butter is produced by Peanut Corporation of America, of Lynchburg, Va., and is distributed in seven states by Ohio-based King Nut Companies. The product was distributed in Minnesota to establishments such as long-term care facilities, hospitals, schools, universities, restaurants, delis, cafeterias and bakeries. King Nut Companies reports that the product is not distributed for retail sale to consumers, and has voluntarily withdrawn the product from distribution.

Minnesota officials continue to coordinate their investigation with the Centers for Disease Control and Prevention, the U.S. Food and Drug Administration and other states.

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FDA Seizes Contaminated Heparin from a Cincinnati Manufacturer

As part of the U.S. Food and Drug Administration's ongoing efforts to ensure that heparin for patients remains safe, the government today seized 11 lots of heparin from Celsus Laboratories Inc. in Cincinnati, Ohio.

The five lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and six lots of Heparin Lithium were seized at the FDA's request by U.S. Marshals. These products, which were manufactured from material imported from China, had been found by the agency to be contaminated with over-sulfated chondroitin sulfate (OSCS), a substance that mimics heparin's anticoagulant activity.

“This action will help prevent this contaminated heparin from finding its way into the marketplace," said Mike Chappell, acting associate commissioner for regulatory affairs, FDA.

Heparin is a blood-thinning drug. An API is a substance or mixture of substances that, when delivered in a finished drug product, directly affects the structure or function of the body. Heparin Sodium USP is an API that may be incorporated into finished drug products. Heparin Lithium is used in certain medical devices including vacutainer blood collection tubes, some in vitro diagnostic assays, and as a coating for capillary tubes. Celsus has distributed Heparin Sodium USP and Heparin Lithium to manufacturers in both the United States and abroad.

OSCS contaminant in injectable drug products containing heparin has been linked to multiple adverse events and deaths initially reported to the FDA in January 2008. Since then, the FDA has put in place a comprehensive inspection and import controls program and has acted to remove from the market heparin materials and products contaminated with OSCS. The seized Celsus heparin – which had entered the United States before the establishment of import controls for the drug – was tested for the presence of OSCS as part of this FDA effort.

To date, the agency has initiated 13 recalls of multiple contaminated medical products containing heparin from several companies.

The FDA informed Celsus Laboratories during an April 2008 inspection and again in a May 8, 2008, letter that the company's actions to notify customers about a contaminant in its heparin were insufficient to assure an effective recall. The agency advises manufacturers who may have purchased heparin from Celsus to contact the company to make certain they are not using any heparin from the seized lots because the product does not meet acceptable quality standards.

The FDA has notified Japanese, Canadian, Australian, European Union, and other international authorities of shipments of contaminated heparin from Celsus.

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