The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-1815-2019·Announced 2019-08-21

Infusion Options Recalls Trastuzumab Infusions Due to Sterility Concerns

Infusion Options, Inc. is recalling multiple Trastuzumab infusion bags 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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a lack of assurance of sterility in a drug product, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Infusion Options, Inc. is recalling multiple lots of Trastuzumab intravenous infusion bags (IVPB) in various concentrations (ranging from 114 mg to 781 mg per 250 ml) due to a lack of assurance of sterility. The affected products are prescription-only medications distributed in New York.

The recall is being conducted to address potential sterility issues with the medication. 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.

Patients who have received these infusions should contact their healthcare provider for guidance. Infusion Options, Inc. is the recalling firm located in Brooklyn, NY.

The recalled product

Product
TRASTUZUMAB 427 MG / 250 ml NS IVPB; TRASTUZUMAB 531 MG / 250 ML NS IVPB; TRASTUZUMAB 276 MG / 250 ML NS IVPB; TRASTUZUMAB 360 MG / 250 ML NS IVPB; TRASTUZUMAB 757 MG / 250 ML NS IVPB TRASTUZUMAB 450 MG / 250 ML NS IVPB; TRASTUZUMAB 120 MG / 250 ML NS IVPB; TRASTUZUMAB 164 MG…
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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