The Recall Desk
HighFDA (Drugs)·D-1761-2019·Announced 2019-08-21

Infusion Options Recalls Cyclophosphamide Infusions Due to Sterility Concerns

Infusion Options, Inc. is recalling various Cyclophosphamide infusion products 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 is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in an intravenous product, which poses a risk of harm even without reported injuries.

Plain-English summary

Infusion Options, Inc. is recalling multiple lots of Cyclophosphamide intravenous infusion products (IVPB) in various concentrations and volumes. The recall is being conducted because of a lack of assurance of sterility for the affected products.

The affected products are distributed only in New York. The recall covers all lots within their expiration dates. The specific products include Cyclophosphamide 840 MG / 250 ML NS IVPB, Cyclophosphamide 1112 MG / 250 ML NS IVPB, and other listed concentrations and volumes manufactured by Infusion Options, Inc.

Healthcare providers and patients should stop using the affected products and contact Infusion Options, Inc. for further instructions. The company can be reached at 718-283-7233.

The recalled product

Product
Cyclophosphamide 840 MG / 250 ML NS IVPB; Cyclophosphamide 1112 MG / 250 ML NS IVPB; Cyclophosphamide 1248 MG / 50 ML NS IVPB; Cyclophosphamide 1125 MG / 100 ML NS IVPB; Cyclophosphamide 1000 MG / 500 ML NS IVPB; Cyclophosphamide 1400 MG / 100 ML NS IVPB Cyclophosphamide 1056 MG
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.

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Same hazard · sterility

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