CLASS II Drug recall · Reported 21 Aug 2019 · FDA Enforcement Report
Fluorouracil 560 MG / IVP recalled by Infusion Options
Infusion Options is recalling Fluorouracil 560 MG / IVP, distributed in New York. The recall was initiated on 12 Jun 2019 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1777-2019
- FDA event ID
- 83136
- Recalling firm
- Infusion Options, Brooklyn, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Jun 2019
- FDA classified
- 15 Aug 2019
- Reported
- 21 Aug 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 12 Jun 2019 | Recall initiated by company | |
| 15 Aug 2019 | Classified by FDA | +64 days |
| 21 Aug 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
NY only
Questions about this recall
Is Fluorouracil 560 MG / IVP recalled?
Yes. Infusion Options recalled Fluorouracil 560 MG / IVP on 12 Jun 2019. The recall is Class II and its status is Terminated. Recall number D-1777-2019.
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
All lots within expiry
Where was it sold?
NY only
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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