KV Pharmaceutical shuts generic company, pleads guilty to criminal charges
February 26th, 2010 joshua
KV Pharmaceutical Co. said it will shut down its generic drug manufacturing unit, Ethex, after a history of poor manufacturing practices and failing to keep regulators informed.
Pharmaceutical companies are required to report any errors in the manufacturing process - either mechanical or through contamination - in a timely manner, as a measure to protect patient safety.
KV said it plans to plead guilty to criminal charges that Ethex failed to inform the Food and Drug Administration. It shut the generic drug company after realizing the plea would exclude it from any future government program. A $27.6 million fine accompanies the plea, as pay-back for the cost of dozens of drug recalls due to Ethex manufacturing processes.
According to an AP report, Ethex failed to inform regulators about safety concerns over two drugs: dextroamphetamine (used in the manufacture of the ADHD drug Adderall) and propafenone (used to treat cardiac arrhythmia).
Also, KV was told to stop making some time-release cough and cold medicines in 2008, but ignored that warning and eventually had its facilities raided and those drugs were seized.
KV also had to issue recalls on drugs that were manufactured improperly, producing pills larger than normal, which could lead to dangerous overdoses.
