Fresenius Kabi Issues Voluntary Nationwide Recall of Two Lots of Fluorouracil Injection Due to the Potential for Glass Particulate
Summary
Fresenius Kabi Issues Voluntary Nationwide Recall of Two Lots of Fluorouracil Injection Due to the Potential for Glass Particulate Fresenius Kabi USA, LLC is voluntarily recalling two lots of Fluorouracil Injection, USP 5g/100mL (50mg/mL), 100mL fill in 100mL vials, to the user level due to the potential for glass particulate. The affected lots, distributed between December 6, 2018 and February 20, 2019, are listed below: Products containing glass particulate should not be administered intravenously due to the potential for life-threatening consequences. The company is issuing this notification after finding glass particulate in five vials in retained sample inventory of lot 6120341 during an inspection for a quality investigation. Distributors should notify their customers and direct them to quarantine and discontinue distributing or dispensing any affected lots, and to return the product to Fresenius Kabi. Fresenius Kabi ( ) is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition.
Classifications
AskAI Classifications
LabelsLinked Companies
