Pfizer Inc. is voluntarily recalling Metronidazole, Ciprofloxacin and Ondansetron IV Products due to the presence of floating matter and non-sterility discovered by the manufacturer Claris Laboratories. Non-sterility of a product administered via the intravenous route has the potential to result in infections, which could be fatal, especially in patients who are immunocompromised. Metronidazole and ciprofloxacin injections are intravenous antibiotics used to treat infections. Ondansetron injection is an intravenous product used to treat nausea and vomiting associated with chemotherapy or surgery. These products are supplied in plastic IV bags.
All lots of the following products are affected by this recall: Metronidazole injection USP 500 mg/100 ml flexible IV plastic container (NDC 0069-2390-01); Ciprofloxacin in Dextrose (5%) injection, USP 200 mg / 100; mL flexible plastic container for IV infusion (NDC 0069-4395-19); Ciprofloxacin in Dextrose (5%) injection, USP 400 mg / 200 mL flexible plastic container for IV infusion (NDC 0069-4396-27); and Ondansetron in 5% Dextrose injection 32 mg / 50 mL flexible plastic container (NDC 0069-0700-12).
Pfizer, which began distributing these Claris products to hospitals, wholesalers and distributors in the US market this year under a licensing agreement, is taking rapid action to help ensure patient safety by halting distribution of all sterileinjectable products in IV bags licensed from Claris Lifesciences and voluntarily recalling the products already distributed.