FDA Public Health Alert: Healthcare Professionals Warned Not To Use Certain Intravenous Metronidazole, Ondansetron, and Ciprofloxacin Due To Potential Contamination

Updated June 1, 2010

On May 29, 2010, the U.S. Food and Drug Administration (FDA) alerted healthcare professionals not to use certain intravenous bags of metronidazole, ondansetron, and ciprofloxacin because of potential contamination. FDA has received reports of floating matter in IV bags manufactured by Claris Lifesciences Limited, in Ahmedabad, India. Foreign matter should not be present in a sterile injectable product. Potentially affected products are sold under the Claris, Sagent Pharmaceuticals, Pfizer, and West-Ward Pharmaceuticals labels.

Healthcare professionals should NOT use and should immediately remove from their pharmacy inventories any of the following intravenous (IV) bag products manufactured by Claris and sold under the following labels:

• Claris – metronidazole, ciprofloxacin, ondansetron
• Pfizer – metronidazole, ciprofloxacin, ondansetron
• Sagent Pharmaceuticals – metronidazole, ondansetron
• West–Ward Pharmaceuticals – metronidazole, ondansetron

Patients who have received these products should be observed for signs or symptoms of illness and treated appropriately.

Metronidazole and ciprofloxacin are antibiotics used to treat a variety of infections. Ondansetron is an antiemetic used to treat nausea and vomiting associated with chemotherapy or surgery.

A Claris customer received a complaint of white matter in a bag of metronidazole, and subsequent microbiological analysis identified the matter as a Cladosporium mold. Molds of this type can cause infections in susceptible patients, such as immunocompromised individuals. Another customer complaint of white matter in a bag of ondansetron was received, and that bag is currently under analysis. At this time, FDA is not aware of any reports of injuries due to administration of these products.

Claris is initiating a recall of all lots of these two products, as well as all lots of ciprofloxacin. These products were all manufactured on the same manufacturing line. FDA is investigating the situation and will notify the public when new information becomes available.

Only metronidazole, ciprofloxacin, and ondansetron in IV bags made by Claris and sold under the Claris, Sagent, Pfizer, and West-Ward Pharmaceuticals labels are affected. Sagent does sell IV bags of ciprofloxacin, but they are not made by Claris and are NOT subject to this recall. West-Ward does not sell an intravenous bag formulation of ciprofloxacin.