The FDA is alerting healthcare professionals to a voluntary recall of all sterile injectable products made by Coastal Meds, a compounding pharmacy based in Biloxi, Miss.
While the company issued the recall April 5, the company failed to make the recall public per the FDA’s request. As a result, the federal agency issued a warning to healthcare professionals to dispose of the products.
The recall was initiated after visible particles were found in some of the drug vials intended 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,” the FDA’s recall warning reads. “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.”
To date, no adverse events have been reported to the FDA as a result of the particulate matter discovered in these sterile products.
Please see Warning Letter here!