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(USGovernment-News.Com, June 07, 2013 ) London, UK -- A compounding pharmacy in the St. Petersburg area has decided to recall all the sterile drugs it issued after inspections found safety problems, according to the Food and Drug Administration of the United States.
Federal health inspectors stated they found “exposed rust” as well as “numerous splattered brownish stains” on equipment at the pharmacy. Such rusk was found on the equipment for injectable drug and eye medication materials. The Compounding Shop may now face being under investigation for criminal negligence.
The FDA stated that the Compounding Shop must take action as precaution to ensure the safety of the agency. The FDA also noted that the pharmacy has yet to be implicated in any reports of illness or negative effects stemming from product use.
The Compounding Shop has failed to commend on the matter thus far, and was one of over 30 facilities that was inspected directly by the FDA in 2013. The St. Petersburg establishment is one of a dozen to have its facility forced to recall medication stemming from the investigations.
The crackdown is not a surprising one, as the FDA has looked to tighten rules on safe practices ever since the outbreak of fungal meningitis, which was linked to a compounding center in Massachusetts. More than fifty people were killed in that particular case, and thus the FDA has looked to push hard for stronger safety practices in the field.
"If an injectable drug product that is intended to be sterile is contaminated, it could result in a life-threatening infection in patients," Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a statement. "We do not have reports of patient infections. However, due to concerns about a lack of sterility assurance at the facility and out of an abundance of caution, we have advised the firm to remove its sterile products from the market to protect patients."
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