News & Press: Patient Safety

RXQ Compounding Issues Recall of Sterile Products and Cessation of Production

Thursday, June 20, 2019  

SIS Patient Safety Alert 06/20/2019: RXQ Compounding, LLC Issues Voluntary Nationwide Recall of All Sterile Products within Expiry and Voluntarily Cessation of Production Due to the Lack of Sterility Process Assurance

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.

RXQ Compounding, LLC (“RXQ”) is voluntarily recalling all sterile human and animal products within expiry to the user level due to lack of sterility process assurance associated with the production of the company’s sterile products. In addition, RXQ is voluntarily ceasing all sterile production at its current location as it transitions to a new outsourcing facility.

Administration of a non-sterile product that is intended to be sterile by subcutaneous, intramuscular, intravenous or ocular routes of administration may result in serious injury or death.

To date, RXQ has not received reports of any adverse events related to the sterile products being recalled. However, RXQ is recalling the sterile products out of an abundance of caution.

All lots of unexpired sterile drug products produced at its Athens, Ohio location are being recalled. RXQ's products were distributed to hospitals and practitioners nationwide.

Click here for a full listing of the products, including lot numbers and expiration dates, being recalled.

RXQ is notifying its customers by letter and is arranging for return of all recalled products. Hospitals and practitioners that have these products being recalled should stop using them immediately.

Consumers with questions regarding this recall can contact RXQ between 9 a.m. and 5 p.m. EST by phone at (740) 331-4202 or via email.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

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 06/20/2019


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