Pfizer Recalls IV Drugs Due To Non-Sterility

Pfizer is voluntarily recalling all lots of Metronidazole, Ciprofloxacin and Ondansetron intravenous products due to the presence of floating matter and non-sterility discovered by the manufacturer Claris Laboratories. Non-sterility of the products has the potential to result in infections, which could be fatal, especially in patients who are immunocompromized. Metronidazole and Ciprofloxacin injections are IV antibiotics used to treat infections and Ondansetron injection is an IV product used to treat nausea and vomiting associated with chemotherapy or surgery.

Pfizer began distributing these products to hospitals, wholesalers and distributors in the U.S. market this year under a licensing agreement with Claris Laboratories. Of approximately 1.7 million IV bags licensed for distribution from Claris, approximately 1.3 million, or about 80%, currently remain in Pfizer’s control. To date, Pfizer has not received any customer reports of quality issues related to the medicines from Claris Lifesciences.