The US Food and Drug Administration (FDA) has issued a recall of all non-expired products marketed as sterile made by Coastal Meds LLC, a 503B registered outsourcing facility in Biloxi, Mississippi.
The FDA inspected Coastal Meds at which time it observed “visible particulates and poor sterile production practices, which further raise concerns about particulates in Coastal Meds’ drug products intended for injection,” the administration said in the release.
Coastal Meds initiated a voluntarily recall of all products intended to be sterile on April 5, 2018, but has since failed to inform the public.
The FDA is not aware of any adverse event reports associated with the drug products.