ISSUE: FDA is alerting health care professionals to a voluntary recall of all non-expired products marketed as sterile made by Coastal Meds due to visible particles in some of the drug vials for injection.

BACKGROUND: 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.

RECOMMENDATION: Health care professionals should immediately check their medical supplies, quarantine any sterile drug products intended for injection from Coastal Meds, and not administer them to patients. Health care professionals should make alternative arrangements to obtain any medications they administer to patients from reliable sources that adhere to proper quality standards.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch Safety Alert https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm604630.htm