PlainRecalls
FDA Drug Verify with FDA Drug → Moderate Class II Terminated

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 N

Reported: August 21, 2019 Initiated: June 12, 2019 #D-1779-2019 N/A units

Infusion Options, Inc. issued this FDA Drug recall on August 21, 2019. Classified as Moderate severity (Class II). Approximately N/A units are affected. The recall was issued because: Lack of Assurance of Sterility. This recall notice is sourced from official FDA Drug enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.

Recall Insight

This FDA Drug action (record #D-1779-2019) was formally reported on August 21, 2019, with the manufacturer initiating the action on June 12, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Infusion Options, Inc. is listed as the recalling firm, operating out of Brooklyn, NY. Federal records indicate N/A units are affected.

The documented reason for this recall is: Lack of Assurance of Sterility Distribution data in the federal record shows the product reached: NY only. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 7 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.

Recall Distribution by Severity Class

Severity1Class I (Critical)Class II (Moderate)Class III (Low)
Recall Distribution by Severity Class

Severity

Moderate

Units Affected

N/A

Related Recalls

6

0 from same agency

Product Description

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

Reason for Recall

Lack of Assurance of Sterility

Details

Recalling Firm
Infusion Options, Inc.
Units Affected
N/A
Distribution
NY only
Location
Brooklyn, NY

Recall Profile

Structured summary of the FDA Drug recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Terminated
Recall number D-1779-2019
Date reported August 21, 2019
Date initiated June 12, 2019
Recalling firm Infusion Options, Inc.
Units affected N/A
Distribution NY only

Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.

Frequently Asked Questions

What product 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. Recalled by Infusion Options, Inc.. Units affected: N/A.
Why was this product recalled?
Lack of Assurance of Sterility
Which agency issued this recall?
This recall was issued by the FDA Drug on August 21, 2019. Severity: Moderate. Recall number: D-1779-2019.
Where was the recalled product distributed?
Distribution: NY only.
How do I check if my product is affected by a recall?
Check the product description and recall number (D-1779-2019) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Recall Context

Product recalls are issued when a manufacturer, distributor, or federal agency determines that a product poses a safety risk to consumers. This recall is classified as moderate severity, indicating the product may cause temporary or medically reversible health consequences. Across PlainRecalls, we track 83,000+ recalls from FDA, CPSC, and NHTSA to help consumers stay informed and act quickly when safety issues arise.

Nearby Recalls in This Category

Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.

Compare this recall with Endo-Model Replacement Plateau; Item Number: 15-0027/11; →

Data Sources

Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.

  • Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
  • Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
  • Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
  • Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)

Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.

All federal data sources used on this page

Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).