The FDA made public a voluntary recall of sterile injectable drugs produced by compounder Coastal Meds of Biloxi, Mississippi, after visible particles were found in some vials.
The company issued a voluntary recall in early April, however, after Coastal Meds didn’t make the recall public at the request of the FDA, the agency issued an alert to health care professionals not to use and to dispose of the products manufactured by Coastal.
During a recent inspection of the company’s facility, investigators found visible particulates and poor sterile production practices, raising concerns about particulates in Coastal’s drug products intended for injection.
To date, there have not been any reports of adverse events associated with drug products produced by Coastal. The company is registered as an outsourcing facility.