FDA: PharMEDium recalls 55 lots of compounded sterile drugs
Editor's Note The Food and Drug Administration on January 2 announced the recall by PharMEDium Services (Lake Forest, Illinois) of 55 lots (impacting 25,327 units) of compounded sterile drug products because of a lack of sterility assurance. The recalled products were manufactured in PharMEDium’s Memphis location and distributed nationwide to…
FDA: AuroMedics recalls Ampicillin and Sulbactam for Injection
Editor's Note The Food and Drug Administration (FDA) on January 4 announced the recall by AuroMedics Pharma LLC (Windsor, New Jersey) of one lot of Ampicillin and Sulbactam for Injection USP 1.5 g in a single-dose vial. The recall was issued because the lot (Lot AFOI 17001-A, Expiry date December…
FDA: Class I recall of Agilis Steerable Reprocessed Introducer Sheath
Editor's Note The Food and Drug Administration (FDA) on January 2 classified the recall by Sterilmed (Plymouth, Minnesota) of its Agilis Steerable Reprocessed Introducer Sheath as Class I, the most serious. The sheath's hemostatic valve, which prevents blood from flowing back through the valve, may fail because of an improper…
FDA: Recall of Pharmacist Choice Alcohol Prep Pads
Editor's Note The Food and Drug Administration (FDA) on December 5 announced the recall of 3 lots of Pharmacist Choice Alcohol Prep Pads by Simple Diagnostics (Coral Springs, Florida), which were manufactured by Foshan Flying Medical Products Co Ltd, located in China. The alcohol pads were recalled because of…
FDA: Baxter recalls one lot of injectable amiodarone
Editor's Note The Food and Drug Administration (FDA) on November 15 announced the recall by Baxter International (Deerfield, Illinois) of one lot of Nexterone (amiodarone HCL) 150 mg/100 mL premixed injection because of the presence of particulate matter. The particulate matter was identified as polyethylene, the primary constituent of the…
FDA: Safety Alert for Cardinal Health’s Infant/Child Reduced Energy Defibrillation Electrodes
Editor's Note The Food and Drug Administration (FDA) on November 6 issued a Safety Alert saying that Physio-Control (Redmond, Washington) launched a voluntary field action for specific lots of Infant/Child Reduced Energy Defibrillation Electrodes manufactured by Cardinal Health (Dublin, Ohio). There is an issue with the artwork on the electrodes…
FDA: Recall of prefilled syringes labeled Midazolam that are actually Ondansetron
Editor's Note The FDA announced on November 3 that Fresenius Kabi USA (Lake Zurick, Illinois) is recalling one lot of Midazolam Injection, USP, 2 mg/2 mL packaged in 2 mL prefilled single-use glass syringes because the packages labeled as Midazolam actually contain syringes that are filled with and labeled as…
FDA: Increased rate of major adverse events with Absorb GT1 Bioresorbable Vascular Scaffold
Editor's Note The Food and Drug Administration (FDA) on October 31 issued a Safety Alert saying that interim study results continue to show an increased rate of major adverse cardiac events and Bioresorbable Vascular Scaffold (BVS) thrombosis in patients receiving the Absorb GT1 BVS by Abbott Vascular (Abbott Park, Illinois),…
FDA: SCA pharmaceuticals recalls certain lots of injectable products
Editor's Note The Food and Drug Administration (FDA) on October 21 announced the recall by SCA Pharmaceuticals (Little Rock, Arkansas) of various lots of injectable products. The recall was initiated because of the potential for the products to contain microbial contamination. Many of the recalled products are used in anesthesia,…
FDA updates Safety Alert for St Jude defibrillators
Editor's Note The Food and Drug Administration (FDA) on October 19 issued an updated Safety Alert for implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators by St Jude Medical. Because batteries for the devices may fail earlier than expected, St Jude has made available a new battery performance management tool,…
Free Daily News
- Study: High-paying medical specialty disparity persists as more women pursue surgical professions
- Study quantifies link between preoperative depression, postoperative delirium
- Cardiovascular disease trends raise alarms on primary care
- Study: Kidney transplants safe between donors, patients with HIV
- Study: Women more likely to die from postoperative complications after high-risk surgery
- Study: Same-day aquablation surgery safe for ASCs
- Outpatient, ASC clinicians share perspectives on upcoming NOPAIN Act implementation
- Study dispels orthopedic surgeon turnover myth
- Feds take action on Hurricane-wracked medical supply chain with wartime powers, drug compounding guidance
- Study: Wearable devices improve postoperative physical activity in lung cancer patients