The U.S. Food and Drug Administration (FDA) has told, for a second time, compounder NuVision Pharmacy Inc. to recall all of its sterile drug products after an agency investigation found continued evidence of contamination since it first requested the recall last year. The agency said that given the high rate of contamination found during its June inspection of the facility owned by Dallas-based Downing Labs LLC, which operates NuVision, there was a high likelihood that contaminated units are currently in distribution. The FDA also said the compounder hasn’t remedied the situation since it last recommended a recall in July 2013. FDA Commisioner Melinda K. Plaisier said in a letter:
During this inspection, FDA investigators found that you identified nonsterility in several different lots of drug products intended to be sterile that were produced at your facility. At least 19 purportedly sterile drug product lots produced between June 2013 and May 2014 tested positive for microbial contamination. In addition, three lots failed endotoxin testing.
The FDA said the use of a contaminated drug product that is thought to be sterile could lead to infection, hospitalization and potentially organ damage or death. The formal request letter is not the first time the FDA has warned NuVision about problems with its supposed sterile products. The company recalled one of its products in April 2013, but refused to recall more products despite FDA objections. The FDA also said in the letter that Downing Labs’ investigations were not thorough and did not provide “sound scientific data” to support its conjectures regarding the causes of contamination. Additionally, the corrective measures the compounder took were not effective, the agency said. The FDA said:
The continued failures indicate that Downing Labs has not yet identified and corrected the root causes of the failures. The corrective actions you have implemented are insufficient to address all of the objectionable conditions found at your firm and to assure sterility.
Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a statement that the recall was a result of the FDA’s priority on patient safety. She said:
We recommend health care professionals stop prescribing sterile drugs from Downing Labs because they pose serious potential risks to patients. Patients deserve medications that are safe, effective, and of high quality no matter who makes them, and the FDA will continue to take action to protect patients.
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