Details:

Corporate Authors:
Centers for Disease Control and Prevention (U.S.) ; United States. Food and Drug Administration. ;
Centers for Disease Control and Prevention (U.S.) ; United States. Food and Drug Administration. ; Less -
Description:
Tuesday, June 01, 2010, 10:25 EST (10:25 AM EST) CDCHAN-00314-2010-06-01-ADV-N The U.S. Food and Drug Administration (FDA) is alerting healthcare professionals not to use certain intravenous (IV) bags of metronidazole, ondansetron, and ciprofloxacin because of potential contamination. FDA has received reports of floating matter in IV bags manufactured by Claris Lifesciences Limited, in Ahmedabad, India. Microbiological analysis identified the matter in one of the bags as a Cladosporium mold. Molds of this type can cause infections in susceptible patients, such as immunocompromised individuals. At this time, FDA is not aware of any reports of injuries due to administration of these products. Affected products include any metronidazole, ondansetron, and ciprofloxacin manufactured by Claris Lifesciences Limited and sold under the following labels: Claris, Sagent Pharmaceuticals, Pfizer, West-Ward Pharmaceuticals
Subject:
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Ciprofloxacin
Drug Contamination
Injections, Intravenous
Metronidazole
Ondansetron

Document Type:
HAN Health Advisory ;
Place as Subject:
United States ;
Collection(s):
Health Alert Network (HAN)
Main Document Checksum:
[+]
urn:sha256:0f0e4a1b3a80530ae7b7d6d1371390b64319ca672fc6f349a751655619becc22
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