Pfizer Initiates A Nationwide Voluntary Recall Of All Lots Of Metronidazole Injection, Ciprofloxacin Injection, And Ondansetron Injection Bags Made By Claris Lifesciences Due To Non-Sterility
NEW YORK, N.Y., June 3 – 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 U.S. 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.
Pfizer has distributed these products only in the United States.
This recall is being conducted with the knowledge of the U.S.
Food and Drug Administration.
Pfizer has received no customer reports of quality issues related to the IV bagged medicines from Claris Lifesciences. Pfizer continues to closely monitor its patient database for any safety concerns. Of approximately 1.7 million IV bags licensed for distribution from Claris, approximately 1.3 million, or about 80 percent, currently remain in Pfizer’s control.
Customers should immediately quarantine, discontinue distribution of and return all recalled lots of these products, as well as notify any of their customers to whom they distributed the products. For information about returning recalled products distributed under the “Pfizer Injectables” label, contact Stericycle Inc. at 1-800-805-3093. Any adverse events that may be related to the use of these products should be reported to Pfizer at 1-800-438-1985 at any time, 24 hours a day.
Healthcare professionals should observe patients who received these products for signs or symptoms of infection and treat appropriately. Adverse events that may be related to the use of these products also can be reported to FDA's MedWatch Program by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787 or on the MedWatch website at www.fda.gov/safety/medwatch/default.htm.
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Posted: June 2010