FDA announces recall of Medistat RX’s sterile drug products
09/22/2015 // JusticeNewsFlash // (press release)
U.S. – The U.S. Food and Drug Administration recently announced a recall on all sterile drug products distributed by Medistat RX in Foley, Alabama. The FDA’s notice about the voluntary recall says the recall has been initiated due to possible contamination, and involved products that were distributed between November 1 of last year and September 3, 2015.
Investigators with the FDA and Alabama state inspectors found questionable deficiencies during an investigation. Medistat voluntarily stopped sterile compounding operations earlier this month. Complaints of several adverse events possibly linked to Medistat made drug products have reportedly been received by the FDA.
Says the FDA press release “Contaminated drugs put patients at risk of serious infection. Health care professionals should immediately check their medical supplies, quarantine any drug products marketed as sterile from Medistat, and not administer them to patients. Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.”
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Source: FDA Press Release http://www.fda.gov/Safety/Recalls/ucm461939.htm