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Susan Haigney is managing editor of Pharmaceutical Technologyand Pharmaceutical Technology Europe, firstname.lastname@example.org.
FDA inspections of compounding pharmacies manufacturing sterile-drug products lead to voluntary recalls.
FDA issued an alert on Monday to healthcare providers, hospital supply managers, and pharmacists that sterile-drug products made by ApothéCure and NuVision Pharmacy were produced under conditions that could create a high potential for contamination. Subsequently, both ApothéCure and NuVision announced voluntary recalls of those products. FDA issued the alert based on preliminary findings of ongoing inspections at ApothéCure and NuVision facilities that raised concerns about a lack of sterility assurance.
NuVision Pharmacy is voluntarily recalling all unexpired lots of lyophilized compounds HcG 5000IU-5 mL and Sermorelin/GHRH6-5 mL to the user level. According to an FDA press release, NuVision Pharmacy has received no reports of injury or illness associated with the use of the sterile products. These products were supplied to the offices of licensed medical professionals. NuVision Pharmacy’s sterile products covered under this recall were distributed nationwide. NuVision Pharmacy is notifying its customers by fax or email to return the products to the pharmacy. Consumers or healthcare providers with questions regarding this recall may contact NuVision Pharmacy by phone at 800-914-7435 on Monday through Friday from the hours of 10 am to 6 pm CST, or by e-mail at email@example.com.
ApothéCure is also voluntarily recalling all lots of sterile products compounded by the pharmacy that are not expired to the user level. According to an FDA press release, ApothéCure has received no reports of injury or illness associated with the use of its sterile products. However, out of abundance of caution, ApothéCure has decided to voluntarily proceed with this recall process. The sterile products include all injectables with the clear message, “Independently tested for sterility,” noted on the vials as well as the ApothéCure name. Consumers or healthcare providers with questions regarding this recall may contact the company by phone at 800-969-6601 or 972-960-6601 from the hours of 9:30 am to 6 pm CST Monday through Friday or by e-mail at firstname.lastname@example.org.
FDA advises that patients who have received any product distributed by NuVision or ApothéCure and have concerns should contact their healthcare provider.