FDA Issues Alert for Sterility Issues for ApotheCure, Inc. and NuVision Pharmacy
FDA issues alert about lack of sterility assurance of drug products from ApotheCure, Inc. and NuVision Pharmacy and of forthcoming recallSILVER SPRING, Md., April 15, 2013--The U.S. Food and Drug Administration 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 advises 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. ApotheCure, Inc. and NuVision Pharmacy have informed the FDA that they have initiated a voluntarily 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 FDA’s preliminary findings of sterile production practices and conditions at the site raise concerns about a lack of sterility assurance. Adverse reactions or quality problems experienced with the use of any ApotheCure, Inc. and NuVision Pharmacy products may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Online: www.fda.gov/medwatch/report.htm1
- Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm2 and mail to address on the pre-addressed form
- Fax: 1-800-FDA-0178
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Posted: April 2013