News & Press: Patient Safety

Infusion Options Inc. Issues Recall of All Sterile Products

Friday, June 21, 2019  

SIS Patient Safety Alert 06/21/2019: Infusion Options Inc. Issues Voluntary Nationwide Recall of All Lots of All Sterile Products Due to Lack of Assurance of Sterility

This is an important alert from the Spine Intervention Society. SIS sends Patient Safety Alerts when it receives important information regarding products or services that can impact your patients' safety. When the Food and Drug Administration (FDA) issues a safety alert, or a company announces a recall or market withdrawal, the FDA posts the announcement as a public service. In such cases neither SIS nor the FDA endorse either the product or the company.

Infusion Options Inc. is voluntarily recalling all lots of all sterile products within expiry to the hospital level. These products are being recalled due to a lack of assurance of sterility.

Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death. To date, Infusion Options Inc. has not received any reports of adverse events related to this recall.

Products were distributed in Brooklyn, New York to a hospital. Infusion Options Inc. is notifying its customers by letter and email and is arranging for return of all recalled products.

Consumers with Infusion Options Inc. products should stop using them and return them for destruction. Consumers are urged to contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products.

Direct any questions regarding this recall to Infusion Options Inc. at 718-283-7233, Monday-Friday 9 a.m. to 5 p.m., EST or via email.

Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report online.
  • Regular Mail or Fax: Download the form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

Source: Food and Drug Administration - Accessed 06/21/2019


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