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.
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Assurance of Sterility
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, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
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.
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Reason Lack of Processing Control
Reason Presence of Particulate Matter; glass particulates
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
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