RXQ Compounding Recalls All 'Sterile' Product

Megan Brooks

Disclosures

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.

RXQ is also ending all sterile production at the Athens facility as the company transitions to a new outsourcing facility.

The list of recalled products includes several injectable medicines, including bevacizumab, buffered lidocaine/epinephrine, calcium chloride, calcium gluconate, dextrose, edetate calcium disodium, epinephrine, fentanyl, glutathione, hydromorphone, hydroxocobalamin, ketamine, midazolam, and pyridoxine, among several others.

The complete eight-page list of the recalled products, including lot numbers and expiration dates, is available on the company website. The list can also be downloaded as an Excel spreadsheet from the FDA's website.

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

To date, RXQ has not received any reports of adverse events related to the sterile products that are being recalled. The company said it is recalling the sterile products "out of an abundance of caution."

RXQ is notifying its customers by letter and is arranging for the return of all recalled products. Hospitals and healthcare professionals who have any of the recalled products should stop using them immediately.

Consumers with questions regarding this recall can contact RXQ between 9 AM and 5 PM EST by phone at (740) 331-4202 or by emailing Brian Post at Brian.Post@RXQCompounding.com.

Adverse events related to the use of these products should be reported to the FDA's MedWatch Adverse Event Reporting program.

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