FDA: Vital Rx, dba Atlantic Pharmacy and Compounding recall all lots of compounded injectable drugs
Editor's Note The Food and Drug Administration (FDA) on August 18 announced the recall by Vital Rx, dba Atlantic Pharmacy and Compounding (Pompano Beach, Florida) of all lots of compounded injectable medications because of sterility assurance. During a recent FDA inspection, investigators observed unsanitary conditions, including poor sterile production practices.…
FDA: Bella Pharmaceuticals recalls all sterile drug products
Editor's Note The Food and Drug Administration on August 18 announced the recall by Bella Pharmaceuticals (Chicago, Illinois) of all lots of unexpired sterile drug products because of a lack of sterility assurance. Affected products include all lots distributed April 17, 2017, to August 10, 2017, nationwide. Products are packaged in…
FDA: Class I recall of Zenith Alpha Thoracic Endovascular Graft by Cook Medical
Editor's Note The Food and Drug Administration (FDA) on August 16 classified the recall by Cook Medical Inc (Bloomington, Indiana) of its Zenith Alpha Thoracic Endovascular Graft as Class I, the most serious. Cook Medical is aware of reported cases where the graft became blocked or closed with blood clots…
FDA: Class I recall of Datascope Corp/Maquet intra-aortic balloon pump
Editor's Note The Food and Drug Administration (FDA) on August 4 classified the recall by Datascope Corp/Maquet (Mahwah, New Jersey) of its intra-aortic balloon pump as Class I, the most serious. The recall was issued because of the risk of a valve failure, which prevents the balloon from inflating and…
FDA: ICU Medical recalls one lot of 0.9% sodium chloride injection, USP 1,000 mL
Editor's note The Food and Drug Administration (FDA) on July 31 announced the recall by ICU Medical, Inc (San Clemente, California) of one lot of 0.9% sodium chloride injection, USP 1,000 mL. The recall was issued because of a confirmed customer complaint of particulate matter identified as stainless steel in…
FDA: All ED-530XT duodenoscopes by Fujifilm recalled
Editor's Note The Food and Drug Administration (FDA) on July 21 announced the recall by Fujifilm of its ED-530XT duodenoscopes. The recall includes replacement of the ED-530XT forceps elevator mechanism including the o-ring seal, replacement of the distal end cap, and a new operations manual. The FDA cleared the updated…
FDA: Oscor recalls Atar extension cables
Editor's Note The Food and Drug Administration (FDA) on July 6 announced the recall by Oscor Inc (Palm Harbor, Florida) of its Atar extension cables. The recall was initiated because, during use, some of the cables were separating from the connectors at the proximal end. The Atar cable is an…
FDA issues draft guideline on UDI requirements
Editor's Note The Food and Drug Administration (FDA) on June 30 issued a draft guideline: “Product Identifier Requirements Under the Drug Supply Chain Security Act−Compliance Policy.” The draft guidance describes the FDA’s enforcement of requirements related to unique device identification (UDI), specifically those that manufacturers affix or imprint on a…
FDA: Recall of potassium phosphate and succinylcholine chloride by PharMEDium Services
Editor's Note The Food and Drug Administration on June 27 announced the recall by PharMEDium Services of specific lots of potassium phosphate and succinylcholine chloride because of a lack of sterility assurance. The products being recalled were compounded using certain Hospira products, which were recalled on June 15 because microbial…
FDA: Fagron Sterile Services recalls three lots of succinylcholine
Editor's Note The Food and Drug Administration (FDA) on June 23 posted the recall by Fagron Sterile Services (Wichita, Kansas) of three lots of succinylcholine chloride 20 mg/mL 5 mL syringes because of microbial growth detected during a simulation of the manufacturing process. This is a secondary recall of products…
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