The FDA advised health care providers and hospital staff to immediately check their medical supplies and quarantine any sterile products from ApotheCure, Inc. or sterile lyophilized products from NuVision Pharmacy. These products were produced under conditions that could create a high potential for contamination and should not be administered to patients.
The FDA is basing this warning on an ongoing inspection of the ApotheCure and NuVision facilities. The FDA’s preliminary findings of sterile production practices and conditions at the site raised concerns about a lack of sterility assurance. Sterile drug products that are contaminated place patients at risk of serious infection.
The companies have initiated a voluntary recall and will communicate further instructions to purchasers about what to do with the products. Patients who were administered any sterile drug products produced and distributed by ApotheCure, Inc. and any sterile lyophilized product distributed by NuVision Pharmacy and who have concerns should contact their health care providers.
See the FDA Announcement