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  4. 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
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COMPANY ANNOUNCEMENT

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

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

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Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Animal & Veterinary
Drugs
Reason for Announcement:
Recall Reason Description
Lack of Sterility Process Assurance
Company Name:
RXQ Compounding LLC
Brand Name:
Brand Name(s)
RXQ Compounding LLC
Product Description:
Product Description
All sterile human and animal products within expiry.

Company Announcement

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 RXQ transitions into the Company's 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 the Athens, Ohio location are being recalled. RXQ's products were distributed to hospitals and practitioners nationwide.

For a full listing of the products, including lot numbers and expiration dates, being recalled 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 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

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 this product 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: www.fda.gov/medwatch/report.htm
  • Regular Mail or Fax: Download form http://www.fda.gov/MedWatch/getforms.htm 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
  • For unapproved animal drug products, you also should report the problem to the manufacturer or distributor shown on the label and to the store where you purchased the product
  • If you have a question  about  ADE  reporting  or  need  a  hard  copy  of  the  form, contact CVM by email at AskCVM@fda.hhs.gov, by phone at 1-888-FDA- VETS (1-888-332-8387)

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Product List


Company Contact Information

Consumers:
Brian Post
(740) 331-4202
Brian.Post@RXQCompounding.com
Media:
David Ball
(617) 243-9950
david@ballcg.com