FDA Warns Against Use of 3 Recalled IV Medications

The US Food and Drug Administration (FDA) is warning healthcare professionals not to use intravenous versions of metronidazole, ciprofloxacin, and ondansetron manufactured by Claris Lifesciences after receiving reports of 2 contaminated intravenous bags.

The medications in question are sold under the labels of Claris, Sagent Pharmaceuticals, Pfizer, and West-Ward Pharmaceuticals. Claris is recalling all lots of these products.

Ciprofloxacin and metronidazole are antibiotics; ondansetron is an antiemetic used to combat nausea and vomiting associated with surgery or chemotherapy.

The FDA announcement on the medications, issued May 29, follows on the heels of the voluntary recall last month of all lots of metronidazole injection, USP 500 mg/100 mL, by Sagent Pharmaceuticals, after Sagent discovered that 2 lots were not sterile.

The FDA stated that it received reports of floating white matter in 2 bags of Claris intravenous medications — 1 involving metronidazole, the other ondansetron. Microbiological analysis identified the substance in the metronidazole bag as a Cladosporium mold, which can cause infections in immunocompromised and other susceptible patients. The white matter in the bag of ondansetron is still being analyzed. The FDA is not aware of any reports of injuries caused by these products.

Claris Touts Lower Manufacturing Costs in India

The metronidazole, ondansetron, and ciprofloxacin being recalled were all produced on the same manufacturing line in the company's facilities in Ahmedabad, India, where Claris is based. The company's Web site states that Claris has 5 manufacturing facilities in Ahmedabad, some of them approved by the FDA.

In April, the company filed for an initial public offering of its stock with the Securities and Exchange Board of India. The company plans to expand its manufacturing capabilities with the capital it hopes to raise.

India has a booming pharmaceutical industry led by generic drug makers such as Claris. These companies have lower manufacturing costs than competitors in Western Europe and North America — a fact touted by Claris in the prospectus for its initial public offering. Multinational pharmaceutical companies such as Pfizer have contracted with Indian generic drug makers to distribute their products.