Coastal Meds has recalled its sterile injectable drugs, the U.S. Food and Drug Administration (FDA) says. The company, based in Biloxi, Mississippi, recalled the products after finding visible particles in some of the vials.
According to the FDA, Coastal Meds initiated a voluntary recall of its sterile products on April 5, 2018, but the company did not alert the public. The regulatory authority is now alerting healthcare professionals of the recall and advising to dispose of any products produced and distributed by the company.
During inspections in March and April 2018, the FDA found poor sterile production practices and visible particles in vials for its products meant for injection use.
This is not the first time the FDA discovered issues with the company’s manufacturing process. FDA inspectors over the last three years found that the drug maker had produced batches of its weight loss products and vitamins for injection with sterility and potency issues. Some batches were not properly tested and sampled before passing the quality control process.
Some injections also lacked labels that explain dosage strength and the expiration date. Some were labeled “not for resale,” the FDA said.
The FDA said that injecting a drug that contains particulate matter could cause “serious and potentially life threatening adverse events, such as infection, allergic reaction, toxicity, or other reactions.”
No adverse reactions have been reported to the FDA as of yet.
Healthcare professionals should check their medical supplies and quarantine all injectable sterile drug products from Coastal Meds. These products should not be administered to patients. Alternative arrangements should be made to obtain these medications from sources that adhere to the appropriate quality standards.
Patients and healthcare professionals are advised to report adverse events and side effects related to the use of Coastal Meds’ injectable sterile drugs to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.