FDA Announces Recall of ApothéCure and NuVision Products

Megan Brooks

Disclosures

April 16, 2013

Drug products made by 2 Dallas, Texas–based compounding pharmacies were produced under conditions that could create a "high potential for contamination," the US Food and Drug Administration (FDA) said in a recall announced April 15.

ApothéCure Inc is voluntarily recalling all lots of sterile products compounded by the pharmacy that are not expired.

NuVision Pharmacy is voluntarily recalling all unexpired lots of all lyophilized compounds HcG 5000 IU-5 mL and Sermorelin/GHRH6-5 mL. Photos of the product labels for these products are available on the FDA Web site.

The recalls are being initiated because of a lack of sterility assurance and concerns associated with the quality control processes identified during FDA inspections, the companies said.

"These products should not be administered to patients," the FDA says.

Immediate Action Required

The agency is asking healthcare providers and hospital staff to "immediately check their medical supplies and quarantine any sterile products from ApothéCure, Inc or sterile lyophilized products from NuVision Pharmacy."

The FDA recommends that facilities and healthcare providers who have received the affected products keep them quarantined until ApothéCure and NuVision Pharmacy issue public notifications and communicate further instructions to purchasers on what to do with the products.

Patients who have received any of the affected products and who have concerns are being advised to contact their healthcare provider.

The FDA says the alert is based on an ongoing inspection of the ApothéCure 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," the agency says.

The ApothéCure and NuVision alert follows a similar alert issued last week involving Green Valley Drugs of Henderson, Nevada. As reported by Medscape Medical News, the company voluntarily recalled all lots of all sterile products compounded, repackaged, and distributed by the pharmacy because of a lack of sterility assurance.

More information about the ApothéCure and NuVision recall is available on the FDA Web site.

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.

Comments

3090D553-9492-4563-8681-AD288FA52ACE
Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.
Post as:

processing....