Recalls / Class II
Class IID-1777-2019
Product
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
- Affected lot / code info
- All lots within expiry
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Infusion Options, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 5924 13th Ave, N/A, Brooklyn, New York 11219-4934
Distribution
- Quantity
- N/A
- Distribution pattern
- NY only
Timeline
- Recall initiated
- 2019-06-12
- FDA classified
- 2019-08-15
- Posted by FDA
- 2019-08-21
- Terminated
- 2025-03-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1777-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.