Lack of sterility assurance prompts companies to withdraw drugs
The US Food and Drug Administration (FDA) has issued an alert to healthcare providers, hospital supply managers and pharmacists that sterile drug products made by ApotheCure and sterile lyophilised drug products made by NuVision Pharmacy were produced under conditions that could create a high potential for contamination.
These products should not be administered to patients, it warns, advising healthcare providers and hospital staff to immediately check their medical supplies. Any affected products found should be placed in quarantine until ApotheCure and NuVision Pharmacy issue public notification and communicate further instructions to purchasers on what to do with them.
ApotheCure and NuVision Pharmacy are understood to have initiated a voluntarily recall of all the products affected.
The FDA is basing this warning on an ongoing inspection of the ApotheCure and NuVision facilities; its preliminary findings of sterile production practices and conditions at the site raised concerns about a lack of sterility assurance.