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Intravenous Medications Manufactured by Claris: Recall due to contamination of products

Sat, 05/29/2010 - 7:20pm
FDA MedWatch

Metronidazole, Ciprofloxacin and Ondansetron sold under the Claris, Sagent Pharmaceuticals, Pfizer, and West-Ward Pharmaceuticals labels.

 

Audience: Pharmacists, Hospital Risk Managers

FDA notified healthcare professionals not to use the intravenous medications, metronidazole, ciprofloxacin and ondansetron manufactured by Claris Lifesciences due to contamination. These products were all manufactured on the same manufacturing line and sold under the Claris, Sagent Pharmaceuticals, Pfizer, and West-Ward Pharmaceuticals labels. The FDA received reports of floating matter in intravenous bags of metronidazole and ondansetron. 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 initiating a recall of all lots of these products. FDA is further investigating the situation and will notify the public when new information becomes available.

Please review the linked Public Health Alert for a list of the affected and recalled products.

 

[05/29/2010 - Public Health Alert - FDA]

 

    

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