The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1750-2019·Announced 2019-08-21

Infusion Options Recalls Avastin Infusions Due to Sterility Concerns

Infusion Options, Inc. is recalling various Avastin infusion products because of a lack of assurance of sterility. The recall is limited to New York.

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 and involves a lack of assurance of sterility in a drug product, which poses a risk of serious health consequences such as infection, meeting the criteria for a Severe rating.

Plain-English summary

Infusion Options, Inc. is recalling multiple lots of Avastin (bevacizumab) intravenous infusion bags and syringes. The products are being recalled due to a lack of assurance of sterility. The affected products include various concentrations of Avastin in 0.9% NaCl or NS IVPB formats, as well as specific syringe sizes.

The recall is limited to distribution in New York. All lots within their expiry dates are affected. The manufacturer is Infusion Options, Inc., located in Brooklyn, NY.

Consumers and healthcare providers should stop using the affected products and contact Infusion Options, Inc. for further instructions. This recall is classified as FDA Class II.

The recalled product

Product
AVASTIN 630 MG / 100 ML 0.9% NACL IVPB; AVASTIN 2.5 mg/ 0.1ML Syringe; AVASTIN 587.5 MG/100 ML 0.9% NACL IVPB; AVASTIN 350 MG/100 ML 0.9% NACL IVPB; AVASTIN 325 MG / 100 ML 0.9% NACL IVPB; AVASTIN 3.75 mg/ 0.15 ML Syringe; AVASTIN 416 MG / 100 ML 0.9% NACL IVPB; AVASTIN 360…
Manufacturer
Infusion Options, Inc.
Category
Drug — 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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