Get breaking news alerts via email

Click here to manage your alerts
FDA warns of compounded drug recall by firm
Product safety » Unsanitary conditions found at Unique Pharmaceuticals plant in Texas.
First Published Jul 23 2014 03:23 pm • Last Updated Jul 23 2014 03:23 pm

Washington • The Food and Drug Administration warned doctors Wednesday not to use compounded drugs from a Texas specialty pharmacy due to potential risks of contamination.

The agency says FDA inspectors recently uncovered unsanitary conditions at Unique Pharmaceuticals’ plant in Temple, Texas. The inspections revealed production problems in several drug lots that were supposed to be sterile.

Join the Discussion
Post a Comment

"Using these products puts patients at an unacceptable risk for serious infection," said Carol Bennett, an official in the FDA’s drug center.

At the behest of regulators, Unique Pharmaceuticals has recalled all non-expired, sterile products distributed across the U.S., including a fluid used to clear mucus in patients with respiratory conditions. The company has also halted production of all other sterile drugs, which are generally solutions administered via injection or intravenous infusion. A spokesman for the company said it continues to produce other forms of drugs that do not require sterile conditions.

"We are diligently working to address FDA’s concerns noted before the recall," said David Shank, in a statement. "We have commissioned third-party independent experts to address those concerns and ensure the safety of our compounded preparations for our customers." Shank added that the recall could contribute to shortages of medicines already in short supply.

The FDA said in a statement it is not aware of any illnesses linked to the recalled products.

Unique Pharmaceuticals is a compounding pharmacy, which means it produces customized medications ordered by physicians. Last week the FDA warned physicians not to use drugs from another Texas compounding pharmacy, NuVision Pharmacy of Dallas, due to potential contamination.

Compounding operations have been repeatedly linked to contamination problems for decades, most recently a 2012 meningitis outbreak triggered by contaminated injections from a large Massachusetts pharmacy that shipped tens of thousands of drugs across the country. In the wake of the outbreak, Congress passed new laws increasing federal oversight of large, mass-production compounding pharmacies. Unique Pharmaceuticals is one of about 50 of these so-called "outsourcing facilities" that have voluntary registered with the FDA. The facilities are required to meet many of the same quality and production standards as traditional pharmaceutical manufacturers.

Copyright 2014 The Salt Lake Tribune. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

Top Reader Comments Read All Comments Post a Comment
Click here to read all comments   Click here to post a comment

About Reader Comments

Reader comments on sltrib.com are the opinions of the writer, not The Salt Lake Tribune. We will delete comments containing obscenities, personal attacks and inappropriate or offensive remarks. Flagrant or repeat violators will be banned. If you see an objectionable comment, please alert us by clicking the arrow on the upper right side of the comment and selecting "Flag comment as inappropriate". If you've recently registered with Disqus or aren't seeing your comments immediately, you may need to verify your email address. To do so, visit disqus.com/account.
See more about comments here.
Staying Connected
Contests and Promotions
  • Search Obituaries
  • Place an Obituary

  • Search Cars
  • Search Homes
  • Search Jobs
  • Search Marketplace
  • Search Legal Notices

  • Other Services
  • Advertise With Us
  • Subscribe to the Newspaper
  • Access your e-Edition
  • Frequently Asked Questions
  • Contact a newsroom staff member
  • Access the Trib Archives
  • Privacy Policy
  • Missing your paper? Need to place your paper on vacation hold? For this and any other subscription related needs, click here or call 801.204.6100.