The affected product (batch number 2310083) was manufactured by CoreRx in Clearwater, Fla., and distributed nationwide between December 2023 and 2024, according to a Sept. 17 FDA news release.
The release warned microbial contamination poses a serious risk, especially for immunocompromised individuals, as it can lead to life-threatening infections, including inflammation of the heart and permanent soft tissue damage.
Consumers are advised to stop using the affected batch and return it to the place of purchase, the release said.
At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.