The FDA is advising physicians not to use certain IV bags of the antibiotics metronidazole and ciprofloxacin and the antiemetic ondansetron because of potential mold contamination.
The agency said in a June 1 public health alert(www.fda.gov) that it had received reports of floating matter in intravenous bags manufactured by Claris Lifesciences Ltd. in Ahmedabad, India. In a June 1 news release(www.fda.gov), Claris said that it was recalling the products as a precautionary measure.
The FDA said health care professionals should not use, and should remove from their pharmacy inventories, IV bag products manufactured by Claris and sold under the following labels:
- Claris (metronidazole, ciprofloxacin, ondansetron);
- Pfizer Inc. (metronidazole, ciprofloxacin, ondansetron);
- Sagent Pharmaceuticals Inc. (metronidazole, ondansetron); and
- West-Ward Pharmaceutical Corp. (metronidazole, ondansetron).
Ciprofloxacin IV bags distributed by Sagent are not manufactured by Claris and are not subject to the recall, according to the FDA.
The agency said microbiological analysis of white matter in a bag of metronidazole identified the substance as a Cladosporium mold, which can cause infections in susceptible patients, including immunocompromised individuals.
Sagent said in a June 2 news release that such infections can be fatal. However, the FDA said it is not aware of any reports of injuries linked to administration of the recalled products.
White matter in a bag of ondansetron -- which is used to treat nausea and vomiting associated with chemotherapy or surgery -- also is being analyzed, said agency officials.
Patients who have received the recalled products should be observed for signs or symptoms of illness and treated appropriately.
Claris said questions about returning unused product should be directed to the company at (877) 725- 2747. Health care workers with medical questions about the products may call the same number and ask for medical affairs, the company said.
Adverse events associated with the use of recalled products should be reported to the FDA's MedWatch program(www.fda.gov).