Summary
- Company Announcement Date:
- June 18, 2019
- FDA Publish Date:
- June 18, 2019
- Product Type:
- Animal & Veterinary
Drugs - 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: 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
- EST by phone at (740) 331-4202 or e•mail: Brian.Post@RXQCompounding.com.
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.htmor 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.
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