Infusion Options Recalls Abraxane Infusions Due to Sterility Concerns
Infusion Options, Inc. is recalling specific Abraxane 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 recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric for drug recalls involving potential serious health consequences.
Plain-English summary
Infusion Options, Inc. is recalling Abraxane 170 MG / 34 ML IVPB, Abraxane 200 MG / 40 ML IVPB, and Abraxane 180 MG / 36 ML IVPB. The recall is being conducted because of a lack of assurance of sterility for these products.
The affected products are prescription-only (Rx Only) and were distributed in New York. The recall covers all lots within their expiration dates. The manufacturer is located at 5924 13th Ave, Brooklyn, NY 11219-4934.
Consumers and healthcare providers should stop using the affected products and contact Infusion Options, Inc. at 718-283-7233 for further instructions.
The recalled product
- Product
- Abraxane 170 MG / 34 ML IVPB; Abraxane 200 MG / 40 ML IVPB; Abraxane 180 MG / 36 ML IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
- Manufacturer
- Infusion Options, Inc.
- Category
- Drug — Chemotherapy
- 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.
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