Sample Inventory Sheet – sample inventory sheet
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Recall Reason Description
Potential for bottle particulate
Fresenius Kabi USA, LLC is voluntarily abandoning two lots of Fluorouracil Injection, USP 5g/100mL (50mg/mL), 100mL ample in 100mL vials, to the user akin due to the abeyant for bottle particulate. The afflicted lots, broadcast amid December 6, 2018 and February 20, 2019, are listed below:
First Ship Date
Last Ship Date
Products absolute bottle chapped should not be administered intravenously due to the abeyant for life-threatening consequences. Letters in the abstract advance that sequelae of thromboembolism, such as pulmonary emboli, phlebitis, granulomas, or fibrosis may occur.
To date, Fresenius Kabi has not accustomed any complaints or letters of adverse contest accompanying to this recall.
The aggregation is arising this notification afterwards award bottle chapped in bristles vials in retained sample account of lot 6120341 during an analysis for a affection investigation. The additional lot (6120420) is included in the anamnesis as a basic admeasurement as it was produced in the aforementioned bushing campaign.
Fluorouracil is a chemotherapy biologic that is administered intravenously and adumbrated for the analysis of a array of cancers.
Fresenius Kabi is advice its distributors and barter by letter and allurement barter and distributors to analysis their banal anon and to apprehension and abandon the use and administration of any afflicted product. Distributors should acquaint their barter and absolute them to apprehension and abandon distributing or dispensing any afflicted lots, and to acknowledgment the artefact to Fresenius Kabi. The anamnesis letter and acknowledgment anatomy are accessible at https://www.fresenius-kabi.com/us/pharmaceutical-product-updates.
Consumers with questions apropos this anamnesis may acquaintance Fresenius Kabi at 1-800-551-7176 Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. or via email at productcomplaint.USA@fresenius-kabi.com or adverse.events.USA@freseniuskabi.com Consumers should acquaintance their physician or bloom affliction provider if they accept accomplished any problems that may be accompanying to demography or application this biologic product.
Adverse reactions or affection problems accomplished with the use of this artefact may be appear to the FDA’s MedWatch Adverse Event Advertisement affairs either online, by approved mail or by fax.
This anamnesis is actuality conducted with the ability of the U.S. Food and Biologic Administration.
About Fresenius Kabi
Fresenius Kabi (www.fresenius-kabi.com/us) is a all-around bloom affliction aggregation that specializes in medicines and technologies for infusion, admixture and analytic nutrition. The company’s articles and casework are acclimated to advice affliction for alarmingly and chronically ill patients. The company’s U.S. address is in Lake Zurich, Illinois. The company’s all-around address is in Bad Homburg, Germany. For added advice about Fresenius Kabi worldwide, amuse appointment www.fresenius-kabi.com.