Thursday, June 20, 2019

RXQ Compounding, LLC, has launched a nationwide recall of all unexpired sterile human products (as well as animal products) produced at its Athens, Ohio, facility because they can't be sure the products are sterile, owing to production problems, according to a company announcement posted on the US Food and Drug Administration (FDA) website.


Company Announcement Date:
June 18, 2019
FDA Publish Date:
June 18, 2019
Product Type:
Animal & Veterinary
Reason for Announcement:
Lack of Sterility Process Assurance
Company Name:
RXQ Compounding LLC
Brand Name:
RXQ Compounding LLC
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: Link Disclaimer.
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:
  • Regular Mail or Fax: Download form 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, 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.

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