News & Press: Patient Safety

Recall Alert: All Sterile Products From Coastal Meds

Friday, April 13, 2018  
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SIS Patient Safety Alert 04/13/2018: All Sterile Products from Coastal Meds: Recall - Visible Particles in Drug Vials for Injection

This is an important alert from the Spine Intervention Society. SIS sends Patient Safety Alerts when it receives important information regarding products or services that can impact your patients' safety. When the Food and Drug Administration (FDA) issues a safety alert, or a company announces a recall or market withdrawal, the FDA posts the announcement as a public service. Neither SIS, nor the FDA endorse either the product or the company.

ISSUE: The U.S. Food and Drug Administration is alerting health care 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. 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.

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.

Coastal Meds is registered as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The Drug Quality and Security Act, signed into law on Nov. 27, 2013, added a new section 503B to the FD&C Act. Under section 503B, a compounder can elect to register as an outsourcing facility. Drugs compounded by an outsourcing facility can qualify for exemptions from the FDA approval requirements, the requirement to label products with adequate directions for use, and the Drug Supply Chain Security Act, but not from current good manufacturing practice requirements.

RECOMMENDATION: 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 care professional.

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: 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 FDA MedWatch Safety Alert for further details.

Source: Food and Drug Administration - Accessed 04/13/201


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