Medication Monitor

Generic Name (Trade Name—Company)
April 17, 2018

Sterile injectable products

(No trade names—Coastal Meds)
FDA announces nationwide recall of all sterile products from Coastal Meds

FDA is alerting health professionals to a voluntary recall of all nonexpired products marketed as sterile that were made by Coastal Meds, of Biloxi, MI. During a recent inspection, FDA investigators observed visible particulates and poor sterile production practices in products 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. Health professionals should immediately check their medical supplies, quarantine any sterile drug products intended for injection from Coastal Meds, and not administer them to patients.

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 the company has not done so.

To date, FDA is not aware of any reports of adverse events associated with drug products produced by Coastal Meds. Patients who have received drug products produced by Coastal Meds and have concerns should contact their health professional.