FDA Alerts Healthcare Professionals To Voluntary Recall Of Sterile Products

Recalls The FDA is alerting healthcare professionals to a voluntary recall of all non-expired products marketed as sterile made by Coastal Meds LLC, of Biloxi, Mississippi, due to visible particles in some of the drug vials for injection. Injection of a drug product containing particulate matter may result in serious and potentially life threatening adverse events, such as infection, allergic reaction, toxicity, or other reactions. Healthcare professionals should immediately check their medical supplies, quarantine any sterile drug products intended for injection from Coastal Meds, and not administer them to patients. Healthcare professionals should make alternative arrangements to obtain any medications they administer to patients from reliable sources that adhere to proper quality standards. During FDA’s recent inspection of Coastal Meds investigators observed visible particulates and poor sterile production practices, which further raise concerns about particulates in Coastal Meds’ drug products intended for injection. On April 5, 2018, Coastal Meds initiated a voluntarily recall of all products intended to be sterile. FDA requested the compounder inform the public, but they have not done so. Therefore, FDA is alerting health care professionals to dispose of and not administer sterile drug products intended for injection that were produced and distributed by Coastal Meds. To date, FDA is not aware of any reports of adverse events associated with drug products produced by Coastal Meds.