The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1779-2019·Announced 2019-08-21

Infusion Options Recalls Fluorouracil Infusions Due to Sterility Concerns

Infusion Options, Inc. is recalling various Fluorouracil infusion products in New York due to a lack of assurance of sterility.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in a drug product, which aligns with the 'Severe' criteria for significant injury risk or Class II classifications with potential for serious harm.

Plain-English summary

Infusion Options, Inc. is recalling multiple formulations of Fluorouracil infusion products. The recall is being conducted due to a lack of assurance of sterility in the affected products.

The recall covers various concentrations and volumes of Fluorouracil, including IVP, CASS, and pump configurations. The distribution pattern is limited to New York. All lots within expiry are affected.

Consumers and healthcare providers in New York who have received these products should contact Infusion Options, Inc. for further instructions. No specific lot numbers or dates are provided in the source text.

The recalled product

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…
Manufacturer
Infusion Options, Inc.
Category
Drug — Antineoplastic
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All lots within expiry

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 76 recalled by Infusion Options, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 76 products in this recall →

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