West-Ward Pharmaceuticals Inc., of Eatontown, NJ, is voluntarily recalling all lots of Claris LifeSciences Inc. manufactured Ondansetron in 5% Dextrose Injection, supplied in 32mg/50mL Single-Use Plastic Bag Containers and Metronidazole Injection 500mg/100ml USP in Flexible IV Plastic Bag Containers. Claris recently received reports of the presence of floating matter and non-sterility in Ondansetron and Metronidazole. Non-sterile products administered intravenously may cause infections which could be fatal especially in patients who are immuno-compromised.
Ondansetron injection is an intravenous product used to treat nausea and vomiting associated with chemotherapy or surgery. Metronidazole injection is an intravenous antibiotic used to treat infection.
As a result Claris has issued a voluntary recall for specific intravenous bag products. As Claris supplies West-Ward with intravenous bag products, West-Ward is recalling all products manufactured by Claris and distributed by West-Ward to the consumer or user level as a precautionary measure and with the full knowledge of the U.S. Food and Drug Administration.
Customers should immediately quarantine, discontinue distribution and return all recalled lots of these products, as well as notify any of their customers to whom the recalled products were distributed. West-Ward is notifying all direct wholesalers and customers of the recall by letter, and asking each to notify those who purchased the recalled product to immediately return all remaining inventory. To date, the firm has not received any confirmed reports of adverse events or complaints of reduced effectiveness associated with the recalled lots.
Healthcare providers and patients can contact West-Ward customer service if they have questions about the recall. West-Ward customer service may be reached at 1-800-631-2174, Monday thru Friday 8:00am EST to 4:45pm EST.
Healthcare professionals should observe patients who have received these products for signs or symptoms of infection and treat appropriately. Any adverse events that may be related to the use of these products should 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.htm1.
