Rare Letter to Compounding Pharmacy Shows FDA Demanding Recall of Potentially Unsterile Products Latest News | Posted: 7 August 2013

By Alexander Gaffney, RF News Editor 

Safety recalls are regularly conducted in the healthcare products sector, falling along a three-tiered classification system in which the most serious recalls are referred to as "Class 1" recalls. But despite healthcare professionals often seeing the end result of these recalls—a notice, and usually a "voluntary" recall, as opposed to an agency-ordered one—they rarely get a glimpse into how that recall is ordered.

Background

On 18 May 2013, FDA issued two notices regarding products manufactured at NuVision Pharmacy, a Dallas, Texas-based compounding pharmacy. The first was a press statement announcing that products compounded by the company had a "lack of sterility assurance," as evidenced in a recent inspection of the company's Dallas facility.

"FDA investigators observed poor sterile production practices that raise concerns about a lack of sterility assurance of the company’s sterile drug products," the agency wrote.

A second notice posted by FDA was through its MedWatch adverse event reporting program, which recommended that healthcare providers stop using the products immediately and quarantine all remaining supplies.

continue to read here

Another Recall: NuVision Pharmacy Announces Voluntary Nationwide Recall of All Lots of All Lyophilized Products Compounded by NuVision Pharmacy Due to Sterility Assurance Concerns

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

NuVision Pharmacy Announces Voluntary Nationwide Recall of All Lots of All
Lyophilized Products Compounded by NuVision Pharmacy Due to Sterility
Assurance Concerns
 

Contact:
800-914-7435

FOR IMMEDIATE RELEASE - April 15, 2013 - NuVision Pharmacy is voluntarily recalling all unexpired lots of lyophilized compounds HcG 5000IU-5ml and Sermorelin/GHRH6-5ml to the user level. The recall is being initiated due to a lack of sterility assurance and concerns associated with the quality control processes identified during the FDA inspection.

In the event a sterile product is compromised patients are at risk for serious and possible life threatening infections. To date, NuVision Pharmacy has received no reports of injury or illness associated with the use of our sterile products. However, out of abundance of caution and in the interest of our patients, NuVision Pharmacy has decided to voluntarily proceed with this recall process.

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 Health Care 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 atpharmacist@nuvisionpharmacy.com. Patients who have received any product distributed by NuVision Pharmacy and have concerns should contact their healthcare provider.

Adverse reactions or quality problems experienced with the use of any of the recalled drugs 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.htm
• Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
• Fax: 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Apothecure's Voluntary Relinquishment in Florida, Reprimand from Texas, New Pharmacy at Same Address--Thank you Dr. Kenneth Woliner for the Research, Information and Your Comments

Here is Apothecure's voluntary relinquishment. (If anyone needs a copy that is easier to read, email me at stuckrichmond@gmail.com and I will email you the information).

http://ww2.doh.state.fl.us/DocServiceMngr/GetImage.aspx?documentid=MTc0ODExNTQ=&enc=1

APOTHECURE, INC
LICENSE NUMBER: PH21213	Printer Friendly Version

Profession PHARMACY License/Activity Status DISCP-RELINQ/ Qualifications Special Non-Resident License Expiration Date License Original Issue Date 2/28/2015 03/28/2005 Discipline on File Public Complaint YES  Link To Discipline YES  Link To Complaint Address of Record If further information is needed, please contact the Department of Health at (850) 488-0595.

Here is the "reprimand" Gary Osborn, the owner of Apothecure, got from Texas:  

http://www.tsbp.state.tx.us/abo/detail/140606%20R26249%20%20%20%20Osborn%2C%20Gary%20Douglas%20%20ABO%20%23J08026A.pdf

Now that was before he plead guilty to violating the FFDCA, perhaps they'll go back and do something similar to what the Feds did against Thomas Bader of College Pharmacy (revoke his license, make him sell all his shares in the pharmacy to a non-family member): http://www.fda.gov/ICECI/CriminalInvestigations/ucm200282.htm (note well: his conviction was upheld, but the $4.8 million forfeiture was reversed due to an instructional error by the judge).