FDA Recall: RXQ Compounding

FDA Recall: RXQ Compounding Issues Voluntary Nationwide Recall of All Sterile Products within Expiry

RXQ Compounding is voluntarily recalling all sterile human drug 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 RXQ transitions into the company's new outsourcing facility.

For a full listing of the products being recalled, including lot numbers and expiration dates, please follow this link: https://rxqcompounding.com/Recall-List.pdf.

RXQ is notifying its customers by letter and is arranging for return of all recalled products. Hospitals and practitioners who have these products being recalled should stop using them immediately. Consumers with questions regarding this recall can contact RXQ between 9 a.m. and 5:00 p.m., ET at 740-331-4202 or via email at Brian.Post@RXQCompounding.com.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by U.S. Mail, or by fax.

• Online: complete and submit form at https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program.
• U.S. Mail or fax: download form at https://www.fda.gov/MedWatch/getforms.htm or call 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 800-FDA-0178.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. If you have additional questions, please contact Jillian Winans, regulatory affairs specialist, at jwinans@ascrs.org or 703-591-2220.