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news.Pfizer has initiated a voluntary recall of Metronidazole, Ciprofloxacin and Ondansetron IV Products due to the presence of floating matter and non-sterility discovered by the manufacturer Claris Laboratories.
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Pfizer, which began distributing 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 and voluntarily recalling the products already distributed.
Pfizer has distributed these products only in the US. The recall is being conducted with the knowledge of the US FDA.
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.
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.
Reportedly, the products affected by the recall include all lots of the 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).