FDA Alert on certain IV medications

The U.S. Food and Drug Administration (FDA) 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.

Healthcare professionals should NOT use and should immediately remove from their pharmacy inventories any metronidazole, ondansetron, and ciprofloxacin intravenous bags sold under the following labels:

* Claris
* Sagent Pharmaceuticals
* Pfizer
* West–Ward Pharmaceuticals

Only metronidazole, ciprofloxacin, and ondansetron in IV bags sold under the Claris, Sagent, Pfizer, and West-Ward Pharmaceuticals labels are affected. Claris is initiating a recall of all lots of these products. These products were all manufactured on the same production line.

For patients who have received any one of these products, clinicians are advised to stop usage immediately and observe patients for any signs of new infection (e.g., fevers or chills). Clinicians are requested to report any suspected adverse events following use of these products to FDA’s MedWatch program at 1-800-332-1088 or http://www.fda.gov/medwatch.

Clinicians with additional questions may contact the FDA at 1-888-463-6332 begin_of_the_skype_highlighting 1-888-463-6332 end_of_the_skype_highlighting or druginfo@fda.hhs.gov