The FDA is alerting health care providers, hospital supply managers, and pharmacists that sterile drug products compounded by ApotheCure, Inc. and sterile lyophilized drug products from NuVision Pharmacy may have a high potential for contamination. This warning is a result of an ongoing inspection of the ApotheCure and NuVision facilities where preliminary findings raised concerns about a lack of sterility assurance.
Contamination of sterile drug products place patients at risk of serious infection. All health care providers and hospital staff are to immediately check and quarantine any sterile products from ApotheCure or sterile lyophilized products from NuVision Pharmacy.
Both companies have initiated a voluntary recall of all sterile products made and distributed by ApotheCure and all sterile lyophilized products made and distributed by NuVision Pharmacy (HcG 5000IU 5mL and Sermorelin/GHRH6 5mL). Patients who were administered any of the affected products are to contact their health care providers.
For more information call (888) INFO-FDA or visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm348156.htm.