Certain IV Drugs Potentially Contaminated

After receiving reports of floating matter in intravenous (IV) bags manufactured by Claris Lifesciences Limited, in Ahmedabad, India, the U.S. Food and Drug Administration (FDA) released a public health alert on May 29 notifying health care professionals that they should not use and should immediately remove from their pharmacy inventories any of the following 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

The products are suspected to be contaminated with mold. 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.

According to the FDA, 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.

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 also sells IV bags of ciprofloxacin, but they are not made by Claris and are not subject to this recall. West-Ward does not sell an IV bag formulation of ciprofloxacin.


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