Audience: pharmacists, hospital risk managers
May 29, 2010 — The FDA notified health care professionals not to use the intravenous medications, metronidazole, ciprofloxacin and ondansetron manufactured by Claris Lifesciences due to contamination. These products were all manufactured on the same manufacturing line and sold under the Claris, Sagent Pharmaceuticals, Pfizer, and West-Ward Pharmaceuticals labels.
The FDA received reports of floating matter in intravenous bags of metronidazole and ondansetron. Foreign matter should not be present in a sterile injectable product.
Health care professionals should not use these products and should immediately remove them from their pharmacy inventories. Claris is initiating a recall of all lots of these products. The FDA is further investigating the situation and will notify the public when new information becomes available.
Please review the public health alert for a complete list of recalled products.
June 2, 2010 — Press release
