July 01, 2010

 

 IV antiemetic, antimicrobials recalled for potential contamination

posted June 18, 2010
 

Claris Lifesciences of Ahmedabad, India, has issued a recall in the U.S. market of intravenous bags of the antiemetic ondansetron and the antimicrobials ciprofloxacin and metronidazole because of potential contamination.

The Food and Drug Administration received reports of floating matter in IV bags manufactured by Claris. The FDA and Centers for Disease Control and Prevention subsequently warned health care professionals not to use ondansetron, ciprofloxacin, or metronidazole IV bags under the labels of Claris, Sagent Pharmaceuticals, Pfizer, or West-Ward Pharmaceuticals.

Analysis of white matter in an IV bag of metronidazole manufactured by Claris identified the substance as a Cladosporium mold, which can cause infection in susceptible patients. At press time, analysis was under way of white matter in an IV bag of ondansetron manufactured by Claris.

Claris has recalled all lots of metronidazole and ondansetron IV bags and all lots of ciprofloxacin IV bags, which the company manufactures on the same line. The FDA was not aware of any reports of adverse events caused by administration of these products.

The FDA will notify the public when new information becomes available. Clinicians with additional questions can contact the agency's Division of Drug Information at (888) 463-6332 or druginfo@fda.hhs.gov.