The FDA conducted an inspection of Downing Labs’ facility Dallas in July 2014 and cited poor conditions and practices that raised concerns regarding the sterility of drug products manufactured there.
The FDA has issued a formal request to Downing Labs to initiate a recall of all sterile drug products in which they cite at least 19 claimed sterile drug product lots tested positive for microbial contamination.
“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,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research.
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