FDA Warns of Compounded Drug Recall by Texas Pharmacy

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.

“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.