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…

Read More

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…

Read More

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.  …

Read More

Editor's Note A new congressional investigation shows that the number of infections from contaminated duodenoscopes is much higher than previously estimated, the April 15 Los Angeles Times reports. The Food and Drug Administration (FDA) told investigators that from 300 to 350 patients at 41 facilities in the US and abroad…

Read More

Editor's Note The Food and Drug Administration (FDA) on April 15 issued draft guidance on “Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act.” Hospital pharmacies or standalone pharmacies that are part of a health system provide compounded drugs for administration in the hospital or health…

Read More

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…

Read More

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…

Read More

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…

Read More

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…

Read More

Editor's Note The Food and Drug Administration (FDA) on March 21 announced the recall by Hospira, Inc (Lake Forest, Illinois) of one lot of 8.4% Sodium Bicarbonate Injection, USP (NDC: 0409-6625-02, Lot 56-148-EV, Expiry August 1, 2017). The recall was initiated because of the presence of a particulate in a single-dose…

Read More