Fluorouracil 560 MG / 11.2 ML IVP Fluorouracil 3340 MG QS 92 ML 0.9% NACL Fluorouracil…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Lack of Assurance of Sterility

What was recalled

Fluorouracil 560 MG / 11.2 ML IVP Fluorouracil 3340 MG QS 92 ML 0.9% NACL Fluorouracil 3920 MG QS 92 ML 0.9% NACL Fluorouracil 3760 mg QS 100 ml NS CASS Fluorouracil 4000 MG QS 92 ml 0.9% NACL Fluorouracil 3140 MG QS 240 ML NS PUMP Fluorouracil 2400 MG QS 96 ML 0.9% NACL Fluorouracil 5000 MG QS 101 ml 0.9% NACL Fluorouracil 750 MG / 15 ML IVP Fluorouracil 4500 mg QS 100 ml NS CASS Fluorouracil 4100 mg QS 100 ml NS CASS Fluorouracil 690 mg / 13.8 ml IVP Fluorouracil 2400 MG QS 96 ML NS IV Fluorouracil 812 MG/16.24 ML IVP Fluorouracil 4872 MG QS 240 ML NS PUMP Fluorouracil 4200 mg QS 100 ml NS CASS Fluorouracil 1110 MG QS 96 ml NS IVPB Fluorouracil 370 MG/ 50 ML NS Fluorouracil 620 MG/ 12.4 ML SYRINGE IVP Fluorouracil 3160 MG QS 92 ML 0.9% NACL Fluorouracil 1050 mg QS 92 ml NS IVPB Fluorouracil 370 MG /100 ML NS IVPB Fluorouracil 4080 MG QS 1000 ML NS IVPB Fluorouracil 5 MG / 0.1 ML SYRINGE Fluorouracil 5040 MG QS 101 ml NS CADD Fluorouracil 4224 MG QS 100 ml NS CASS Fluorouracil 700 MG / 14 ML IVP Fluorouracil 3550 mg QS 92 ML 0.9% NACL IV Fluorouracil 760 MG / 15.2 ML IVP Fluorouracil 4560 MG QS 240 ML NS PUMP Fluorouracil 796 MG / 15.92 MLIVP Fluorouracil 4776 MG QS 240 ML NS PUMP Fluorouracil 930 MG QS 240 ML NS PUMP Fluorouracil 730 MG / 14.6 ML IVP SYR Fluorouracil 4400 MG QS 100 ml NS CADD Fluorouracil 2430 MG QS 96 ml 0.9% NACL Fluorouracil 4728 MG QS 100 ml NS CASS Fluorouracil 3550 MG QS 92 ML 0.9% NACL Fluorouracil 588 MG / 11.76 ML IVP Fluorouracil 3528 MG QS 240 ML NS PUMP Fluorouracil 2520 mg QS 96 ml NS IVPB Fluorouracil 790 MG / 15.8 ml IVP Fluorouracil 4750 mg QS 97 ml 0.9% NACL IV Fluorouracil 2660 MG QS 96 ml NS IVPB Fluorouracil 720 MG/ 14.4 ML IVP Fluorouracil 4370 mg QS 92 ml 0.9% NACL IV Fluorouracil 3280 MG QS 92 ML 0.9% NACL Fluorouracil 780 MG / 15.6 ML IVP Fluorouracil 4660 MG QS 97 ml 0.9% NACL Fluorouracil 3620 MG QS 100 ml NS CASS Fluorouracil 2370 MG QS 92 ML 0.9% NACL Fluorouracil 800 MG / 16 ML IVP Fluorouracil 4800 MG QS 101 ml NS CADD Fluorouracil 4000 mg QS 92 ML 0.9% NACL IV Fluorouracil 2480 MG QS 96 ML 0.9% NACL Fluorouracil 688 MG / 13.76 ml IVP Fluorouracil 4128 MG QS 1000 ML D5W IVPB Fluorouracil 6000 MG QS 250 ml NS CASS Fluorouracil 672 MG / 13.44 ML IVP Fluorouracil 4032 MG / 1000 ML D5W IVPB Fluorouracil 894 MG / 17.88 ml IVP Fluorouracil 400 MG / 50 ML NS IVPB Fluorouracil 840 MG / 16.8 ml IVP Fluorouracil 590 MG/ 11.8 ML IVP

Recalling firm: Infusion Options, Inc.
Origin: NY, United States
Initiated by: Voluntary: Firm initiated
FDA recall number: D-1779-2019

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Fluorouracil recalls

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Class II · Moderate risk Terminated Dec 22, 2022

5-Fluorouracil 1%, 2.5ML droptainer, and 5ML droptainer Ophthalmic, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Pharmacy Innovations D-0190-2023

Class II · Moderate risk Terminated Apr 6, 2020

Fluorouracil (5-FU) 4.5% Cream 100 GM, tube Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Reason Lack of Processing Control

The Medicine Shoppe Pharmacy D-1177-2020

Class I · High risk Terminated Jun 28, 2019

Fluorouracil Injection, USP, 5 g / 100 mL (50 mg / mL), 100 mL fill in a 100 mL vial, Rx Only, Mfd. by: Fresenius Kabi, Lake…

Reason Presence of Particulate Matter; glass particulates

Fresenius Kabi USA, LLC NDC 63323-117-69 D-1489-2019

Class II · Moderate risk Terminated Jun 12, 2019