Fresenius Kabi USA is voluntarily recalling three lots of famotidine injection vials due to out-of-specification endotoxin results.
Famotidine injection is approved for some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, according to a Nov. 7 FDA recall alert. Elevated endotoxin levels were found in reserve samples from one of the medication lots, prompting the lot’s recall and two others as a precaution.
Elevated endotoxin levels can trigger sepsis and septic shock. “Non-serious adverse event reports potentially associated with” the out-of-specification levels, such as chills and change of mental status, have been received for one lot, the FDA said. To date, no adverse event reports have been received for the other two lots.
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.