Infusion Options Recalls Bevacizumab Infusions Due to Sterility Concerns
Infusion Options, Inc. is recalling various Bevacizumab 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 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 hazard involves a lack of assurance of sterility in an intravenous product, which carries a risk of serious infection.
Plain-English summary
Infusion Options, Inc. is recalling multiple lots of Bevacizumab intravenous infusion bags (IVPB) in various concentrations. The recall is being conducted due to a lack of assurance of sterility. The affected products are prescription-only medications manufactured by Infusion Options, Inc. in Brooklyn, New York.
The recall is limited to New York. The source text indicates that all lots within the expiration date are affected. No specific lot numbers, dates, or unit counts are provided in the source material.
Consumers and healthcare providers should stop using the affected products and contact Infusion Options, Inc. for further instructions.
The recalled product
- Product
- BEVACIZUMAB 784 MG / 100 ML NS IVPB; BEVACIZUMAB 350 MG/100 ml NS IVPB; BEVACIZUMAB 425 MG/ 100 ml NS IVPB; BEVACIZUMAB 420 MG/100 ml 0.9% NACL IVPB; BEVACIZUMAB 556 mg/100 ml NS IVPB BEVACIZUMAB 330 MG / 100 ML NS IVPB; BEVACIZUMAB 790 MG / 100 ML NS IVPB; BEVACIZUMAB 470 MG…
- Manufacturer
- Infusion Options, Inc.
- Category
- Drug — Biologic / Infusion
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 →Related recalls
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