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FDA Issues Alert About Lack of Sterility of Drug Products

Two manufacturers cited (Apr. 15)

The FDA is alerting health care providers, hospital supply managers, and pharmacists that sterile drug products made by ApotheCure, Inc. and sterile lyophilized (freeze-dried powder) 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.

Sterile drug products that are contaminated place patients at risk of serious infection, the FDA warns. The agency advises health care providers and hospital staff to immediately check their medical supplies and to quarantine any sterile products from ApotheCure, Inc. or sterile lyophilized products from NuVision Pharmacy.

ApotheCure, Inc. and NuVision Pharmacy have informed the FDA that they have initiated a voluntary recall of all sterile products made and distributed by ApotheCure, Inc. and all sterile lyophilized products made and distributed by NuVision Pharmacy. Facilities and health care providers who have received the affected products should keep them quarantined until ApotheCure Inc. and NuVision Pharmacy issue public notification and communicate further instructions to purchasers on 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 have concerns should contact their health care providers.

The FDA is basing this warning on an ongoing inspection of the ApotheCure and NuVision facilities. The agency’s preliminary findings of sterile production practices and conditions at the sites raise concerns about a lack of sterility assurance.

Source: FDA; April 15, 2013.

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