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FDA Issues Alert For IV Bags

Mon, 06/14/2010 - 6:58am

The Food and Drug Administration (FDA) is alerting health care professionals not to use certain IV bags of ondansetron, metronidazole, and ciprofloxacin because of potential contamination. The FDA has received reports of floating matter in IV bags manufactured by Claris Lifesciences in Ahmedabad, India. Microbiological analysis identified the matter in one of the bags as a Cladosporium mold. Molds of this type can cause infections.

At this time the FDA is not aware of any related incidents. Affected products include any ondansetron, metronidazole, and ciprofloxacin manufactured by Claris Lifesciences and sold under the following labels: Claris, Sagent Pharmaceuticals, Pfizer, and West-Ward Pharmaceuticals. Ondansetron is an antiemetic used to treat nausea and vomiting associated with chemotherapy or surgery. Metronidazole and ciprofloxacin are antibiotics used to treat a variety of infections. While the FDA is still learning more about the situation, health care professionals should NOT use and should immediately remove from their pharmacy inventories any metronidazole, ondansetron, and ciprofloxacin intravenous bags sold under the labels listed above.

Clinicians are requested to report any suspected adverse events following use of these products to the FDA's MedWatch program at (800) 332-1088 or www.fda.gov/medwatch. Clinicians with additional questions may contact the FDA at (888) 463-6332 or druginfo@fda.hhs.gov.

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