The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1777-2019·Announced 2019-08-21

Infusion Options Recalls Fluorouracil Infusions Due to Sterility Concerns

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

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 recall is classified as FDA Class II. According to the rubric, an FDA Class II recall involving a drug with a sterility defect (which carries a risk of serious infection) is categorized as Severe (Score 4), as it is not a Class I recall but involves a significant potential for harm.

Plain-English summary

Infusion Options, Inc. is recalling multiple Fluorouracil infusion products, including various concentrations and volumes of 0.9% NaCl and NS solutions, as well as IVP and syringe formats. The recall is being conducted because of a lack of assurance of sterility for these products.

The affected products are distributed only in New York. The recall covers all lots within their expiration dates. Infusion Options, Inc. is located in Brooklyn, New York.

Patients who have received these products should contact their healthcare provider for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

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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