The Recall Desk
SevereFDA (Drugs)·D-1771-2019·Announced 2019-08-21

Infusion Options Recalls Doxorubicin Liposomal Infusions Due to Sterility Concerns

Infusion Options, Inc. is recalling Doxorubicin Liposomal and combination chemotherapy infusions 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. According to the rubric, an FDA Class II recall involving a significant hazard such as lack of sterility in an intravenous chemotherapy product warrants a 'Severe' rating (Score 4), as it poses a risk of serious injury or hospitalization, even if specific injury reports are not detailed in the provided text.

Plain-English summary

Infusion Options, Inc. is recalling specific lots of Doxorubicin Liposomal and combination chemotherapy infusions. The affected products include Doxorubicin Liposomal 71 MG / 250 ML D5W IVPB, Doxorubicin Liposomal 66 MG/250 ML D5W, Doxorubicin 16 MG/1000 ML NS IV WITH Vincristine 0.6 MG and Etoposide 78 MG, and Doxorubicin 45 MG / 22.5 ML IVP SYRINGE. The recall covers all lots within their expiration dates.

The reason for the recall is a lack of assurance of sterility. This means the manufacturer cannot guarantee that the products are free from microbial contamination. The distribution of these products was limited to New York.

Healthcare providers and patients who have received these products should contact their healthcare provider for further instructions. Infusion Options, Inc. is the recalling firm.

The recalled product

Product
Doxorubicin Liposomal 71 MG / 250 ML D5W IVPB; Doxorubicin Liposomal 66 MG/250 ML D5W, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 Doxorubicin 16 MG/1000 ML NS IV WITH Vincristine 0.6 MG and Etoposide 78 MG Doxorubicin 16 MG/1000 ML
Manufacturer
Infusion Options, Inc.
Category
Drug — Chemotherapy 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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Same hazard · sterility

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