For the second time in a week, the U.S. Food and Drug Administration (FDA) has warned about issues with <"http://www.yourlawyer.com/practice_areas/defective_drugs">Claris Lifesciencesâ€™ injectable drugs. Last week, the FDA issued a Public Health Alert; this week, the FDA is announcing a recall initiated by Claris Lifesciences. Claris Lifesciences is voluntarily recalling of all lots of the following:
â€¢ Ciprofloxacin Inj. USP 200 mg / 100 mL (NDC 36000-008-24)
â€¢ Ciprofloxacin Inj. USP 400 mg / 200 mL (NDC 36000-009-24)
â€¢ Metronidazole Inj. USP 500 mg/100 ml (NDC 36000-001-24)
â€¢ Ondansetron in 5% Dextrose Inj. 32 mg / 50 mL (36000-014-06)
Patients who have received these products should be observed for signs or symptoms of illness and treated appropriately.
Metronidazole and Ciprofloxacin are antibiotics used to treat a variety of infections. Ondansetron is an antiemetic used to treat nausea and vomiting associated with chemotherapy or surgery.
The recalled injectable drugs were manufactured and distributed by Claris Lifesciences; all lots are being recalled and were distributed to hospitals, wholesalers, and distributors nationwide.
Claris has initiated this voluntary recall against possible contamination due to packaging integrity of the product. Claris received reports of floating matter, which may pose a risk to patients. Foreign matter should not be present in a sterile injectable product.
Healthcare professionals should NOT use these products, and should immediately remove them from their pharmacy inventories. Claris is not aware of any adverse patient events resulting from this product.
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, Monday through Friday, 8:00 am to 7:00 pm, Central Standard Time. Healthcare workers who have medical questions about the products may contact the same number and ask for Medical affairs. Adverse events should be reported to Claris customer helpline number at 1-877-725-2747, or FDA’s Med Watch Program by fax at 1-800-FDA-0178; by U.S. 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.