Mold Contamination of Metronidazole, Ondansetron, and Ciprofloxacin Intravenous Products - June, 2010

The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control (CDC) are warning healthcare professionals to prohibit use of all lots of metronidazole, ondansetron, and ciprofloxacin I.V. bags manufactured by Claris Lifesciences Limited. These products are sold under the following labels: Claris, Sagent Pharmaceuticals, Pfizer, and West-Ward Pharmaceuticals. Concerns of floating materials in these products, including evidence of mold ( Cladosporium spp) contamination, have prompted the recall of these products by Claris. Clinicians are urged to discontinue use of these specific products and carefully monitor any patients who may have received them for signs of infection. Any suspected adverse events should be promptly reported to MedWatch at 800-332-1088 or http://www.fda.gov/medwatch .

For more information, U.S. healthcare professionals may refer to the following website: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPati...

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