FDA warns duodenoscope manufacturers on postmarket study noncompliance
Editor's Note The Food & Drug Administration (FDA) on March 9 issued warning letters to all three duodenoscope manufacturers for failing to comply with federal requirements to conduct postmarket surveillance studies to assess the effectiveness of reprocessing their devices. Olympus failed to start data collection, and Pentax and Fujifilm failed…
FDA: Recall of methylprednisolone sodium succinate for injection
Editor's Note The Food and Drug Administration (FDA) on March 6 announced the recall by Sagent Pharmaceuticals (Schaumburg, Illinois) of 10 lots of methylprednisolone sodium succinate for injection, USP, 40 mg, 125 mg, and 1 g. The recall was initiated because of the discovery of high out of specification impurity…
FDA: Hospira recalls three lots of hydromorphone HCL injection
Editor's Note The Food & Drug Administration (FDA) on March 5 announced the recall by Hospira (Lake Forest, Illinois) of three lots of hydromorphone HCL injection, USP Cll 10 mg/mL, 1 mL in 2 mL single dose vials. The recall was initiated because units from these lots may be empty…
FDA issues warning for compounded drugs from Cantrell Drug Company
Editor's Note The Food & Drug Administration (FDA) on March 2 issued a warning for healthcare professionals not to use drug products produced by Cantrell Drug Company (Little Rock, Arkansas), including opioids and other drugs intended for sterile injections. The FDA is concerned about serious deficiencies in Cantrell’s compounding operations,…
FDA issues Safety Alert for clarithromycin
Editor's Note The Food and Drug Administration (FDA) on February 22 issued a Safety Alert for clarithromycin (Biaxin) because of the potential increased risk of heart problems or death associated with this antibiotic in patients with heart disease. A large clinical trial with 10-year follow-up found an unexpected increase in…
Agencies issue voluntary protocols for duodenoscope surveillance sampling, culturing
Editor's Note The Food & Drug Administration, Centers for Disease Control & Prevention (CDC), American Society for Microbiology, along with other experts on February 26 released voluntary standardized protocols for duodenoscope surveillance sampling and culturing, which update a 2015 CDC interim protocol. For facilities that choose to implement duodenoscope surveillance…
FDA: Class I recall of certain Medtronic ICDs, CRT-Ds
Editor's Note The Food & Drug Administration (FDA) on February 27 classified the recall by Medtronic of certain Implantable Cardiovert Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) as Class I, the most serious. The recall was initiated because of a defect in the manufacturing process. The defect causes an…
FDA: Hospira recalls four lots of Labetalol Hydrochloride
Editor's Note The Food and Drug Administration (FDA) on February 23 announced the recall by Hospira Inc (Lake Forest, Illinois) of three lots of Labetalol Hydrochloride Injection, USP, 100 mg/20 mL vial (NDC 0409-2267-25), and one lot of Labetalol Hydrochloride Injection, USP, Novaplus (NDC 0409-2267-25). The recall was initiated because…
FDA permits marketing of new blood test for concussions
Editor's Note The Food & Drug Administration (FDA) on February 14 authorized marketing of the first blood test to help evaluate concussions in adults and reduce the need for CT scans. The Banyan Brain Trauma Indicator works by measuring levels of proteins (ie, UCH-L1 and GFAP) that are released from…
FDA permits marketing of software to alert providers of potential strokes in patients
Editor's Note The Food & Drug Administration (FDA) on February 13 announced that it is permitting the marketing of clinical decision support software that alerts providers to potential strokes in their patients. The Viz.AI Contact application is designed to analyze computed tomography images of the brain and send a text…
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