[6-15-2015] The U.S. Food and Drug Administration is alerting health care providers, researchers and patients not to purchase or use drugs labeled or marketed as sterile by ScienceLab.com due to the possibility of products being contaminated.
FDA is alerting health care providers to immediately check their inventory and quarantine any drug products labeled as sterile from ScienceLab.com, and not to administer them to patients. Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.
Patients who may have received any product produced by ScienceLab.com and who have concerns should contact their health care provider.
FDA investigators inspected the headquarters of ScienceLab.com in Houston, Texas and observed conditions that could result in a lack of sterility of purportedly sterile drug products, which puts patients at risk.
FDA is not aware of reports of illness associated with the use of these products at this time.
FDA asks health care providers to report to FDA if they have sterile product from ScienceLab.com in inventory by sending an email to: CDERDrugSupplyChainIntegrity@fda.hhs.gov.
In addition, FDA asks health care providers, researchers and patients to report adverse events or quality problems associated with the use of ScienceLab.com’s products to FDA’s MedWatch Safety Information and Adverse Event Reporting Program: