Infusion Options Recalls Doxorubicin Syringes Due to Sterility Concerns
Infusion Options, Inc. is recalling various Doxorubicin IV syringes 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, and the hazard involves a lack of assurance of sterility in IV products, which poses a significant risk of serious injury or infection.
Plain-English summary
Infusion Options, Inc. is recalling multiple lots of Doxorubicin IV syringes and combination IV infusions. The products are being recalled because of a lack of assurance of sterility. The affected products include various concentrations of Doxorubicin in IVP syringes, as well as Doxorubicin combined with Vincristine and Etoposide in NS IV solutions.
The recall is limited to distribution in New York. All lots within their expiration dates are affected. The products are prescription-only and are manufactured by Infusion Options, Inc. in Brooklyn, NY.
Healthcare providers and patients should stop using these products and contact Infusion Options, Inc. for further instructions or a replacement.
The recalled product
- Product
- Doxorubicin 110 MG / 55 ML IVP SYRINGE; Doxorubicin 56 MG / 28 ML IVP SYRINGE; Doxorubicin 75 MG / 37.5 ML IVP SYRINGE; Doxorubicin 125 MG / 62.5 ML SYRINGE IVP; Doxorubicin 93 MG / 46.5 ML IV SYRINGE; Doxorubicin 112 MG / 56 ML IVP SYRINGE; Doxorubicin 50 MG / 25 ML IVP…
- Manufacturer
- Infusion Options, Inc.
- Category
- Drug — IV 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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