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.
What this means for you
Illness, injury, or structural failure has been reported. 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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