The Recall Desk
HighFDA (Drugs)·D-1757-2019·Announced 2019-08-21

Infusion Options Recalls Carfilzomib Infusions Due to Sterility Concerns

Infusion Options, Inc. is recalling various strengths of Carfilzomib infusions 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 risk of harm (infection) from a lack of sterility assurance, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Infusion Options, Inc. is recalling multiple strengths of Carfilzomib (65 mg, 75 mg, 50 mg, 45 mg, and 46.2 mg) in 50 mL D5W IVPB. The recall is being conducted due to a lack of assurance of sterility for the affected products.

The affected products are prescription-only infusions distributed in New York. The recall covers all lots within their expiration dates.

Consumers and healthcare providers should stop using the affected products and contact Infusion Options, Inc. at 718-283-7233 for further instructions.

The recalled product

Product
CARFILZOMIB 65 MG IN 50 ML D5W IVPB; CARFILZOMIB 75 MG IN 50 ML D5W IVPB; CARFILZOMIB 50 MG IN 50 ML D5W IVPB; CARFILZOMIB 45 MG IN 50 ML D5W IVPB; CARFILZOMIB 46.2 MG IN 50 ML D5W IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233

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 →