The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1749-2019·Announced 2019-08-21

Atezolizumab Infusion Recalled for Lack of Sterility Assurance

Infusion Options, Inc. is recalling Atezolizumab 1200 mg/250 mL 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, and the rubric specifies that FDA Class II recalls with potential for serious injury (implied by sterility issues in IV products) or significant injury reports fall under Severe. While no specific injuries are reported, the 'Lack of Assurance of Sterility' for an IV infusion represents a significant risk of serious harm (sepsis/infection), aligning with the Severe criteria for significant injury potential or high-risk contamination.

Plain-English summary

Infusion Options, Inc. is recalling Atezolizumab 1200 mg / 250 mL 0.9% NaCl, a prescription-only infusion product. The recall is being conducted because of a lack of assurance of sterility. The product is distributed in New York only, and all lots within expiry are affected.

The FDA has classified this recall as Class II. Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
ATEZOLIZUMAB 1200 MG / 250 ML 0.9% NACL, 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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