IV antibiotics, antiemetic recalled due to possible contamination
By JENNIFER WALKER-JOURNEY

Date: June 2nd, 2010

Two intravenous (IV) antibiotics used to treat a variety of infections and an antiemetic used to treat nausea and vomiting associated with chemotherapy or surgery are being recalled by the manufacturer because the products may be contaminated, according to a public health alert issued by the Food and Drug Administration (FDA).

The recalled products include intravenous bags of the antibiotics metronidazole and ciprofloxacin and the antiemetic ondansetron. The drugs are sold under the Claris, Sagent Pharmaceuticals, Pfizer and West-Ward Pharmaceuticals labels.

The FDA has received reports of floating matter in IV bags manufactured by Claris Lifesciences Limited, in Ahmedabad, India. Foreign matter in should not be present in a sterile injectable product. The agency received a complaint of white matter in a bag of metronidazole. A subsequent microbiological analysis identified the matter as a Cladosporium mold. Molds of this type can cause infections in some patients, such as those with compromised immune systems. Another customer complaint of white matter in a bag of ondansetron was received and that bag is currently under analysis. At this time, the agency is not aware of any injuries associated with these products.

Health care professionals are urged not to use the drugs and to remove them from their pharmacy inventories. Patients who have received these products should be observed for signs or symptoms of illness and treated appropriately. Any adverse events with these or any other drugs should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch

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