The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1747-2019·Announced 2019-08-21

Infusion Options Recalls Trastuzumab Infusions Due to Sterility Concerns

Infusion Options, Inc. is recalling specific trastuzumab and emtansine 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. Per the rubric, if the agency's own classification is FDA Class I or USDA Class I, the score is never below 4. Since this is Class II, it falls into the Severe category (Score 4) as it involves a significant risk of harm (sterility) without explicit Class I designation or reported fatalities.

Plain-English summary

Infusion Options, Inc. has issued a recall for multiple lots of ADO-TRASTUZUMAB and ADO-TRASTUZUMAB EMTANSINE infusion products. The affected products include various concentrations of trastuzumab and emtansine in 250 ml normal saline, distributed exclusively in New York. The recall is being conducted because the manufacturer lacks assurance of the sterility of these products.

The recall covers all lots within their expiration dates. Infusion Options, Inc. is the recalling firm and is located in Brooklyn, New York. The products are prescription-only intravenous infusions.

Patients who have received these infusions should contact their healthcare provider for guidance. 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 recalled product

Product
ADO-TRASTUZUMAB 210 MG/250 ml NS; ADO-TRASTUZUMAB E 213 MG / 250 ML NS; ADO-TRASTUZUMAB 242 MG/250 ml NS; ADO-TRASTUZUMAB EMT 168 mg / 250 ml NS; ADO-TRASTUZUMAB E 160 MG / 250 ML NS ADO-TRASTUZUMAB 150 mg / 250 ml NS; ADO-TRASTUZUMAB EMT 301 mg / 250 ml NS; ADO-TRASTUZUMAB…
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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