The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1784-2019·Announced 2019-08-21

Infusion Options Recalls Ifosfamide Infusions Due to Sterility Concerns

Infusion Options, Inc. is recalling Ifosfamide and Mesna infusion bags 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 agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls with potential for hospitalization or significant injury reports are rated as Severe (4).

Plain-English summary

Infusion Options, Inc. is recalling Ifosfamide 9200 mg / 1 L NS IVPB with Mesna 9200 mg, prescription-only infusion bags. The recall is limited to New York and includes all lots within their expiration dates.

The FDA has classified this as a Class II recall because the product lacks assurance of sterility. This means there is a reasonable probability that the product could cause temporary or medically reversible health consequences, or that the risk of serious adverse health consequences is remote.

Patients who have received these infusions should contact their healthcare provider with any questions or concerns. The recall is being conducted by Infusion Options, Inc., located in Brooklyn, New York.

The recalled product

Product
IFOSFAMIDE 9200 MG / 1 L NS IVPB WITH MESNA 9200 MG, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Manufacturer
Infusion Options, Inc.
Category
Drug — 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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