FDA Expands Alert to All Sterile NuVision Drug Products

Megan Brooks

Disclosures

May 20, 2013

The US Food and Drug Administration (FDA) is alerting healthcare providers not to use any sterile product made by Dallas, Texas–based compounding pharmacy NuVision Pharmacy because of concerns about a lack of sterility assurance.

In April, as reported by Medscape Medical News, NuVision recalled methylcobalamin injection and lyophilized injection products because of a lack of sterility assurance and because of concerns associated with the quality control processes identified during an FDA inspection.

Risk for Serious Infection

The expanded alert, issued May 18, covers all sterile drug products made and distributed by NuVision.

"The FDA is basing this expanded alert on a recent inspection of the NuVision Dallas facility, during which FDA investigators observed poor sterile production practices that raise concerns about a lack of sterility assurance of the company's sterile drug products," the FDA said.

"If a drug product marketed as sterile has microbial contamination, it potentially places patients at risk of serious infection," the agency warned.

The FDA said it received adverse event reports of fever, influenza-like symptoms, and soreness at the injection site associated with the methylcobalamin injection product that was previously recalled. The agency is not aware of any additional adverse event reports associated with other sterile products from NuVision.

The FDA is asking healthcare providers to immediately check their medical supplies for any sterile drug product from NuVision Pharmacy, quarantine those products, and not administer them to patients. Patients who were administered any sterile drug products produced and distributed by NuVision and who have concerns are being asked to contact their healthcare provider.

According to its Web site, NuVision Pharmacy's areas of compounding include: aesthetics/dermatology, sterile injectables, preservative-free and allergy-free compounds, ophthalmology, prolotherapy, pain management, thyroid/glandular, autoimmune diseases, bioidentical hormone replacement, neurological, antiparasitics, and amino acids/vitamins/minerals, among others.

Health providers can contact NuVision Pharmacy at 800-914-7435 or by e-mail at pharmacist@nuvisionpharmacy.com.

The expanded alert on all sterile drug products from NuVision Pharmacy follows recent recalls of sterile products at other compounding pharmacies for similar problems and concerns about sterility of products after FDA inspections.

As reported by Medscape Medical News, those companies include The Compounding Shop in St. Petersburg, Florida; ApothéCure Inc of Dallas, Texas; Green Valley Drugs in Henderson, Nevada; and Balanced Solutions Compounding Pharmacy of Lake Mary, Florida.

To report problems with these products, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at http://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

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