The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1758-2019·Announced 2019-08-21

Infusion Options Recalls Cetuximab IV Infusions Due to Sterility Concerns

Infusion Options, Inc. is recalling Cetuximab 335 mg/167.5 mL IV infusions 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. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility issues) are classified as Severe (Score 4), as they are not Class I (Critical) but represent a significant risk.

Plain-English summary

Infusion Options, Inc. is recalling Cetuximab 335 mg / 167.5 mL IVPB, a prescription-only intravenous infusion, due to a lack of assurance of sterility. The recall covers all lots within their expiration dates and is limited to distribution in New York.

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, or where the probability of serious adverse health consequences is remote. The specific hazard identified is the potential for the product to be non-sterile.

Patients who have received these infusions should contact their healthcare provider for guidance. Infusion Options, Inc. is the recalling firm responsible for this action.

The recalled product

Product
CETUXIMAB 335 MG / 167.5 ML IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Manufacturer
Infusion Options, Inc.
Category
Drug — Biologic / 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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