The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1787-2019·Announced 2019-08-21

Infusion Options Recalls Irinotecan Infusions Due to Sterility Concerns

Infusion Options, Inc. is recalling various Irinotecan 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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for significant injury or hospitalization (implied by sterility failure in IV products) fall under the 'Severe' category, and the rule states that FDA Class I or II classifications generally map to scores 4 or 5, with Class II typically being 4 unless specific hospitalization reports are present (which are not explicitly detailed here, but sterility failure in IV drugs is a high-risk defect).

Plain-English summary

Infusion Options, Inc. is recalling multiple lots of Irinotecan intravenous infusion products. The affected products include various concentrations of Irinotecan mixed with D5W or NS, such as 250 mg/500 ml, 110 mg/250 ml, and 315 mg/250 ml. These are prescription-only products manufactured by Infusion Options, Inc. in Brooklyn, New York.

The recall was initiated because of a lack of assurance of sterility. The source text does not specify the exact cause of the sterility concern or provide specific lot numbers, stating only that all lots within expiry are affected. The distribution was limited to New York.

Patients who received these infusions should contact their healthcare provider for guidance. The recall is classified as FDA Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
IRINOTECAN 250 MG /500 ml D5W IVPB; IRINOTECAN 110 MG /250 ML D5W IVPB; IIRINOTECAN 250 MG/250 ML NS IVPB; IRINOTECAN 315 MG / 250 ML NS IVPB; IRINOTECAN 155 MG / 500 ml D5W IVPB; IRINOTECAN 75 MG / 250 ML NS IVPB; IRINOTECAN 140 MG / 250 ML NS IVPB; IRINOTECAN 317 MG /500 ML…
Manufacturer
Infusion Options, Inc.
Category
Drug — IV Infusion
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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