FDA: Recall of Well Care Compounding Pharmacy sterile products in Nevada
Editor's Note The Food and Drug Administration (FDA) on May 18 announced the recall by Well Care Compounding Pharmacy of all sterile compounded products because of concern over lack of sterility assurance. The recall is for Nevada and impacts all sterile compounded products distributed between January 1 and April 29,…
FDA drops recall of Custom Ultrasonics’ System 83 Plus endoscope reprocessor
Editor's Note The Food and Drug Administration (FDA) has dropped its recall of approximately 2,800 Custom Ultrasonics’ System 83 Plus automated endoscope reprocessors. This action comes despite the FDA's finding last year that the recall was “necessary to protect public health,” the May 6 Kaiser Health News reports. The FDA…
FDA: Cook recalls all Beacon Tip catheters
Editor's Note The Food and Drug Administration (FDA) on May 4 announced the recall by Cook Medical (Bloomington, Indiana) of all lots of its catheters with Beacon Tip technology. The catheters are used in angiographic, radiographic, interventional, and urologic procedures. The catheters have been found to exhibit polymer degradation of the…
FDA: Fresenius Kabi USA recalls one lot of Sensorcaine-MPF (bupivacaine HCL)
Editor's Note The Food and Drug Administration (FDA) on April 26 announced the recall by Fresenius Kabi USA (Lake Zurich, Illinois) of one lot of Sensorcaine-MPF (bupivacaine HCL) Injection, USP, 0.75%, 7.5 mg/mL, 30 mL fill in a 30 mL vial. The recall was initiated because of the presence of…
FDA: Medtronic recalls battery pack for Capnostream 20, 20p monitors
Editor's Note The Food and Drug Administration announced on April 20 the recall by Medtronic of the battery pack used in its Covidien Oridion labeled Capnostream 20 and Capnostream 20 p patient monitors. Capnostream monitors are external devices used to assess a patient’s respiratory status. The recall was initiated because…
FDA: Pharmakon Pharmaceuticals recalls all sterile compounded products
Editor's Note The Food and Drug Administration (FDA) on April 20 announced that Pharmakon Pharmaceuticals (Noblesville, Indiana) issued a nationwide recall of all sterile compounded products because of a lack of sterility assurance and other quality issues. The sterile products were distributed between March 4 and April 15, 2016. …
FDA: Vascular Solutions recalls Guardian II hemostasis valves
Editor's Note The Food and Drug Administration (FDA) on April 11 announced the recall by Vascular Solutions, Inc (Minneapolis, Minnesota), of specific lots of Guardian II hemostasis valves used in catheterization procedures. The recall was initiated because of an increased risk of air leakage that may lead to an air…
FDA: Boston Scientific recalls Fetch 2 Aspiration Catheter
Editor's Note The Food and Drug Administration (FDA) on April 11 announced the recall by Boston Scientific (Marlborough, Massachusetts) of all models of its Fetch 2 Aspiration Catheter, a thrombectomy catheter used to remove small blood clots from coronary arteries. The recall was initiated because of complaints of shaft breakage…
FDA: B Braun Medical recalls one lot of 5% Dextrose Injection
Editor's Note The Food and Drug Administration on March 29 announced the recall by B Braun Medical (Bethlehem, Pennsylvania) of one lot of 5% Dextrose Injection USP 100/150 mL container (Lot #J5J706, catalog #S5104-5264, NDC -1510-32). The company received customer complaints that some containers exhibited leakage and, in a few…
FDA: All compounded products by Reliable Drug Pharmacy recalled
Editor's Note The Food and Drug Administration (FDA) on March 28 announced that Reliable Drug Pharmacy (San Francisco, California) is recalling all unexpired lots of compounded products because of concerns of lack of quality assurance and potential mislabeling. The recall affects all compounded products distributed between March 24, 2015 and…
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