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In 2006, the FDA sent a warning letter to the compounder that cited, among other things, concerns about marketing anesthetic creams and potential microbial contamination associated with splitting and repackaging Avastin.
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And earlier this week, the compounder recalled all lots of its sterile, unexpired products due to a lack of sterility assurance and concerns with product quality controls ( here is the recall announcement).
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"NECC's transparency in dealing with the board since inception in 1998 demonstrates its good faith intention to operate in compliance with the requirements of its license, " said Paul Cirel, a Boston-based lawyer representing the compounder, in a statement on Tuesday.
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