ST. LOUIS Starting Monday, K-V Pharmaceutical will ship its first product since it withdrew several products in 2008 and 2009 due to manufacturing problems, the drug maker said.
K-V said the Food and Drug Administration had given it approval to ship its Micro-K potassium chloride product following the completion of inspections of its manufacturing plant.
Ethex, K-V’s generic drug marketing and distribution division, pled guilty in February to two felony counts of failing to file alerts to inform regulators of manufacturing problems in 2008, and agreed to pay $27.6 million to the federal government to resolve the investigation. The settlement allowed K-V to continue manufacturing drugs once it had regained compliance with the FDA’s current good manufacturing practices regulations.
In March 2009, the FDA filed an injunction against K-V to prevent it from making or distributing adulterated and unapproved drugs, and forced the company to destroy the drugs it had recalled, forbidding it from resuming manufacturing until it had been brought back into compliance with regulations.
“Today marks a significant milestone in our efforts to restore business operations at K-V,” interim president and CEO Greg Divis stated. “The successful FDA inspection of our facilities and approval of our return to market demonstrates our hard work and commitment to meeting and sustaining current good manufacturing practices requirements.”