The Recall Desk
HighFDA (Drugs)·D-1751-2019·Announced 2019-08-21

Infusion Options Recalls Azacitidine Syringes Due to Sterility Concerns

Infusion Options, Inc. is recalling Azacitidine syringes in New York due to a lack of assurance of sterility.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (sterility issue) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Infusion Options, Inc. is recalling Azacitidine 125 mg / 5 mL, 75 mg (3 mL), and 135 mg / 5.4 mL subcutaneous syringes. The recall is limited to products distributed in New York. The reason for the recall is a lack of assurance of sterility.

The affected products are prescription-only medications. The source text does not specify the number of units recalled or the specific lot numbers, noting only that all lots within expiry are affected. No illnesses or injuries have been reported in the source text.

Patients and healthcare providers should stop using the affected syringes and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
AZACITIDINE 125 MG / 5 ML SUB-Q SYRINGE; AZACITIDINE 75 MG (3 ML) SYRINGE, AZACITIDINE 135 MG / 5.4 ML SUB-Q SYRINGE, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Manufacturer
Infusion Options, Inc.
Category
Drug — Injectable Medication
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.

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Same hazard · sterility

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