FDA Warns of Compounded Drug Recall by Texas Firm
WASHINGTON (AP) — The Food and Drug Administration is warning doctors not to use compounded drugs from a Texas specialty pharmacy due to 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 lots of drugs that were supposed to be sterile.
The company is now recalling 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.
The FDA said in a statement it is not aware of any illnesses linked to the products.
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.