Class II · Moderate risk
5-Fluorouracil 1%
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Fluorouracil 560 MG / 11.2 ML IVP Fluorouracil 3340 MG QS 92 ML…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
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
Drug: Fluorouracil
- Recalling firm
- Infusion Options, Inc.
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1779-2019 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Fluorouracil recalls
See all
Class II · Moderate risk
Fluorouracil
Lack of Processing Control
Class I · High risk
Fluorouracil Injection
Presence of Particulate Matter; glass particulates
Class II · Moderate risk
Fluorouracil 560 MG / 11.2 ML IVP
Lack of Assurance of Sterility
Class II · Moderate risk
Fluororacil 0.05% Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Other recalls by Infusion Options, Inc.
All 2019 recalls
Class II · Moderate risk
FERRIC CARBOXYMALTOSE 750mg/50ml NS IVPB
Lack of Assurance of Sterility
Class II · Moderate risk
Vincristine 1 Mg /50 Ml Ns Ivpb
Lack of Assurance of Sterility
Class II · Moderate risk
Vinblastine 10.9 Mg / 100 Ml D5w Ivpb
Lack of Assurance of Sterility
Class II · Moderate risk
VELCADE 2.1 mg / 0.84 ml SQ SYRINGE
Lack of Assurance of Sterility
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