US Compounding, Inc, of Conway, AR, issued a voluntary recall of all lots of sterile products aseptically compounded and packaged by the company, and that remain within expiry, because of a lack of sterility assurance. The affected sterile products were distributed nationwide to patients, providers, hospitals, and clinics between March 14, 2015, and September 9, 2015. The recall does not apply to any nonsterile compounded medications prepared by US Compounding. Providers and patients are advised to discontinue use of the products, quarantine any unused product, and contact US Compounding to arrange the return of any unused sterile compounded products using the information provided in the FDA press release.
The company has issued this recall out of an abundance of caution. A list of all sterile compounded products that have been recalled is included on FDA’s website. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to using these drug products. Providers who have dispensed any sterile product distributed by US Compounding should contact patients to whom product was dispensed and notify them of this recall. Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.