TEMPLE (July 24, 2014) A day after the U.S. Food and Drug Administration warned doctors not to use compounded drugs from Unique Pharmaceuticals, a specialty pharmacy in Temple, because of risks of contamination, the company said in a statement it “continues to believe that products involved in the recall...are sterile and safe.”
“However, we felt it best, out of an abundance of caution and in order to maintain the confidence of our customers, to recall the products that FDA alleged were compounded without adequate assurances of sterility, and start fresh, the company said Thursday.
The agency said Wednesday it issued the warning FDA inspectors recently uncovered unsanitary conditions at the Unique Pharmaceuticals' plant.
The inspections revealed production problems in several lots of drugs that were supposed to be sterile, the FDA said.
“Health care professionals should immediately check their medical supplies, quarantine any sterile drug products from Unique Pharmaceuticals, and not administer them to patients, as these products may be contaminated,” the FDA said in a press release.
“Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death,” the agency said.
The company recalled all non-expired sterile products distributed across the U.S., including a fluid used to clear mucus from the airways of patients with respiratory conditions.
Using these products puts patients at an unacceptable risk for serious infection,” said Carol Bennett, acting director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research.
“We urge health care professionals to follow recall instructions issued by the firm.”
The FDA said in a statement it is not aware of any illnesses linked to the products, and the company said Thursday “there has never been a sterility failure identified in products released to the public.”
“Unique is temporarily suspending distribution of sterile products to address FDA's concerns about alleged sterility issues at the facility. Unique continues to produce non-sterile preparations,” the company said.
“We are diligently working to address FDA’s concerns noted before the recall. We have commissioned third-party independent experts to address those concerns and ensure the safety of our compounded preparations for our customers, which is our highest priority,” the company said.
Unique Pharmaceuticals is a compounding pharmacy, which means it produces customized medications to fill specifications made by doctors.
Compounding pharmacy operations have been repeatedly linked to contamination problems for decades.