The Recall Desk
SevereFDA (Drugs)·D-1770-2019·Announced 2019-08-21

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.

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, 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 SYRINGE;
Manufacturer
Infusion Options, Inc.
Category
Drug — IV 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 →

Related recalls

Same manufacturer · Infusion Options, Inc.

See all →

Same hazard · sterility

See all →