The U.S. Food and Drug Administration has issued a warning to providers and patients to cease use of any sterile-use drug products made and distributed by Dallas-based Downing Labs "because the firm cannot ensure the safety or quality of these products," according to the FDA.
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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