FDA issues alert on contaminated IV bags

Mold infections could result in patients

The Food and Drug Administration is alerting healthcare professionals not to use certain intravenous (IV) 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. Microbiological analysis identified the matter in one of the bags as a Cladosporium mold. Molds of this type can cause infections in susceptible patients, such as immunocompromised individuals. At this time, FDA is not aware of any reports of injuries due to administration of these products.

Affected products include any metronidazole, ondansetron, and ciprofloxacin manufactured by Claris Lifesciences Limited and sold under the following labels: Claris, Sagent Pharmaceuticals, Pfizer, West-Ward Pharmaceuticals.

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 complaint of white matter in a bag of metronidazole was received, and subsequent microbiological analysis identified the matter as a Cladosporium mold. Another complaint of white matter in a bag of ondansetron was received and that bag is currently under analysis. Foreign matter should not be present in a sterile injectable product.

Infection preventionists with additional questions should contact FDA at 1-888-463-6332 or druginfo@fda.hhs.gov.