Second 503B Compounder This Month Recalls Product Due To Lack Of Sterility

April 13, 2018
FDA alerted health care professionals Friday (April 13) afternoon that Coastal Meds LLC, a registered 503B outsourcing facility, is recalling all of its products marketed as sterile, due to visible particles in some of the drug vials. FDA stepped in to alert the public after the company refused to publicly announce the recall, which it agreed to initiate April 5. The agency states that during a recent inspection “investigators observed visible particulates and poor sterile production practices, which further raise...

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