The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1776-2019·Announced 2019-08-21

Infusion Options Recalls Etoposide Infusions Due to Sterility Concerns

Infusion Options, Inc. is recalling various Etoposide 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 classified this as an FDA Class II recall. According to the rubric, an FDA Class II recall involving a significant risk such as lack of sterility in an IV product is classified as Severe.

Plain-English summary

Infusion Options, Inc. is recalling multiple lots of Etoposide intravenous infusion bags in New York. The affected products include various concentrations of Etoposide (90 mg to 290 mg) in 500 ml volumes of Normal Saline or 0.9% Sodium Chloride. The recall is being conducted because of a lack of assurance of sterility for these products.

The recall covers all lots within their expiration dates. The products are prescription-only and were distributed exclusively in New York. Infusion Options, Inc. is the manufacturer and the firm responsible for the recall.

Healthcare providers and patients should stop using the affected Etoposide infusion bags and contact Infusion Options, Inc. for further instructions or to arrange for the return of the product.

The recalled product

Product
Etoposide 184 MG / 500 ml NS IVPB; Etoposide 176 MG/ 500 ml 0.9% NACL IVPB; Etoposide 170 MG / 500 ml 0.9% NACL IVPB; Etoposide 152 MG / 500 ml 0.9% NACL IVPB; Etoposide 275 MG / 500 ml NS IVPB; Etoposide 270 MG / 500 ml NS IVPB; Etoposide 90 MG / 500 ml NS IVPB; Etoposide 160…
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 →

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