Recall -- Firm Press Release
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Claris Lifesciences initiates a nationwide voluntary recall of all lots of Ciprofloxacin Inj. USP 200 mg / 100 mL, Ciprofloxacin Inj. USP 400 mg / 200 mL, Metronidazole Inj. USP 500 mg/100 ml and Ondansetron Inj., 32 mg / 50 mL.
FOR IMMEDIATE RELEASE - June 1, 2010 - Claris Lifesciences today announces 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 the product listed above to the user level as a precautionary measure against possible contamination due to packaging integrity of the product. Claris is initiating a voluntary recall of the products listed above because it has received reports of floating matter which 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 and 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. The necessary form by which to document this information as well as other information regarding this recall is available at http://www.clarislifesciences.com/Claris_USA/index.asp. Any questions about returning unused product should be directed to the customer call center at +1 (877) 725- 2747, M-F 8am-7pm CST. Healthcare workers who have medical questions about the products may contact the same number and ask for Medical affairs.
Any adverse events that may be related to the use of this product should be reported at Claris customer helpline number at 1-877-725-2747, FDA's Med Watch 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.