Contamination Leads to Recall of Intravenous Drugs by Claris

Foreign matter that was found floating in IV bags has led to a recall for ciprofloxacin, metronidazole, and ondansetron manufactured by Claris Lifesciences. 

The FDA issued a public health alert on May 29, warning healthcare professionals not to use certain intravenous bags of the drugs, which are sold under the Claris, Pfizer, Sagent Pharmaceuticals and West-Ward Pharmaceutical labels.

The intravenous drug recall was issued after white matter was found floating in a bag of metronidazole. An analysis of the particles led to the determination that it was Cladosporium, a form of mold. Similar white matter, still under analysis, was later found in a bag of ondansetron. The mold could cause infections in patients, particularly those with compromised immune systems.

All lots of intravenous bags of ciprofloxacin, metronidazole, and ondansetron made by Claris are affected by the recall. Ciprofloxacin and metronidazole are antibiotics. Ondansetron is an antiemetic for the treatment of nausea from surgery and chemotherapy.

All three drugs are sold by Claris, Pfizer and Sagent Pharmaceuticals. West-Ward Pharmaceuticals only sells metronidazole and ondansetron. Sagent also sells its own ciprofloxacin IV drug, which is not affected by the recall.

The FDA and Claris have advised health care professionals and facilities to examine their inventory immediately and quarantine drugs affected by the recall, stop using them, and return them to Claris. Anyone who has distributed the product to other customers are urged to identify the customers that bought it and alert them to the recall.

For more information regarding the recall, customers should visit the Claris Lifesciences website at http://www.clarislifesciences.com/Claris_USA/index.asp. Anyone who experiences an adverse event related to the recalled drugs should contact FDA’s Med Watch Adverse Event Reporting Program at http://www.fda.gov/Safety/MedWatch/default.htm.