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The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.
Main Street Family Pharmacy, LLC, a compounding pharmacy in Newbern, Tennessee, and the company’s co-owner, David A. Newbaker, each pleaded guilty today in the United States District Court for the Western District of Tennessee to one misdemeanor criminal violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
The pleas are in connection with Main Street’s interstate shipment of methylprednisolone acetate (MPA) that was adulterated under the FD&C Act because the MPA contained microbial contamination. In May 2013, Main Street announced a recall of all of its products compounded for sterile use. This followed 26 reports of adverse events, including skin abscesses, from patients in four states who received MPA injections compounded by Main Street.
For more information, please visit: Main Street Pharmacy
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