The US Food and Drug Administration (FDA) has warned medical device maker Becton Dickinson (BD) for good manufacturing practice (GMP) violations at the company’s Franklin, Wisconsin facility. The ...
SCHAUMBURG, Ill.--(BUSINESS WIRE)--APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc. (NASDAQ:APCVZ), announced today that it has received clearance ...
WASHINGTON, Aug. 20 (UPI) -- Covidien, a healthcare products producer, initiated a voluntary recall of certain lots of Monoject prefill flush syringes, U.S. government officials say. The U.S. Food and ...
APP also did not show that it investigated whether other batches may have been out of spec. "We are also concerned about a potentially related trend of OOS assay results for other batches of heparin ...
Credit: Getty Images. The intent of the document is to help reduce heparin product overdose errors caused by misinterpretation of the drug strength displayed in the labeling. The Food and Drug ...
The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) issued final guidance Wednesday to aid manufacturers in reducing the risk of patient injury associated ...
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