Claris Lifesciences initiates a nationwide voluntary recall

Claris has initiated this voluntary recall of several products as a precautionary measure against possible contamination. Claris Lifesciences today announced the voluntary nationwide recall of all lots of Ciprofloxacin Inj. USP 200 mg / 100 mL (NDC 36000-008-24), Ciprofloxacin Inj. USP 400 mg / 200 mL (NDC 36000-009-24), Metronidazole Inj. USP 500 mg/100 ml (NDC 36000-001-24), and Ondansetron in 5% Dextrose Inj. 32 mg / 50 mL (36000-014-06) manufactured and distributed by Claris Lifesciences. All lots are being recalled, which were distributed to hospitals, wholesalers and distributors nationwide. Claris has initiated this voluntary recall of these products as a precautionary measure against possible contamination due to packaging integrity of the product. Claris has received reports of floating matter that may pose risk if administered to patients. Healthcare professionals should NOT use these products and should immediately remove them from their pharmacy inventories. This recall is made with the full knowledge of the Food and Drug Administration. Claris is not aware of any adverse patient events resulting from this product but is continuing its diligent investigation of the situation. Customers have been instructed to examine their inventory immediately and to quarantine, discontinue distribution of and return all recalled lots of the product. Customers who may have further distributed this product have been requested to identify their customers and notify them at once of this product recall. For more information on reporting adverse effects or returning unused product, please visit theÊFDA’s recall page.

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