Alerts

Mold Contamination of Metronidazole, Ondansetron, and Ciprofloxacin Intravenous Products - Updated June 2010

The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control (CDC) are warning healthcare professionals to prohibit use of all lots of metronidazole, ondansetron, and ciprofloxacin I.V. bags manufactured by Claris Lifesciences Limited. These products are sold under the following labels: Claris, Sagent Pharmaceuticals, Pfizer, and West-Ward Pharmaceuticals.

Health Canada has issued a similar warning to Canadian practitioners regarding all lots of ciprofloxacin 2 mg/mL I.V. bags (100 and 200 mL) manufactured by Claris and distributed in Canada by BioSyent Pharma Inc. The Canadian packaging for these products bears both the BioSyent and Claris names.

Concerns of floating materials in these products, including evidence of mold ( Cladosporium spp) contamination, have prompted the recall of these products by Claris. Clinicians are urged to discontinue use of these specific products and carefully monitor any patients who may have received them for signs of infection. In the U.S., any suspected adverse events should be promptly reported to MedWatch at 800-332-1088 or http://www.fda.gov/medwatch. In Canada, suspected adverse events should be promptly reported to BioSyent Pharma Inc, at 888-439-0013 or Canada Vigilance Program at 866-234-2345.

For more information, healthcare professionals may refer to the following websites:

• U.S.: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPati...
• Canada: http://hc-sc.gc.ca/dhp-mps/alt_formats/pdf/medeff/advisories-avis/prof/201...

U.S. Brand Names

• Cetraxal®
• Ciloxan®
• Cipro®
• Cipro® I.V.
• Cipro® XR
• Proquin® XR

Medication Safety Issues

Sound-alike/look-alike issues:

• Cetraxal® may be confused with cefTRIAXone
• Ciprofloxacin may be confused with cephalexin
• Ciloxan® may be confused with cinoxacin, Cytoxan
• Cipro® may be confused with Ceftin®

Generic Available

Yes: Excludes ointment, otic solution, suspension

Pharmacologic Categories

• Antibiotic, Ophthalmic
• Antibiotic, Otic
• Antibiotic, Quinolone

Related Terms

• Ciprofloxacin Hydrochloride