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Presence of a Foreign Substance: Generic Lipitor

Presence of a Foreign Substance: Generic Lipitor

Atorvastatin is a statin drug prescribed to reduce harmful cholesterol levels and potential incidence of heart disease and stroke.  Sold in 90 and 500 tablet bottles, atorvastatin calcium pills manufactured by Ranbaxy, Inc. are the popular generic alternative to Lipitor, the name brand of the generic atorvastatin.

In early November, Ranbaxy voluntarily recalled lots of its generic atorvastatin pills, about 480,000 bottles, due to the presence of a foreign substance — glass.  While the United States Food and Drug Administration (FDA) states the contaminant may not be a significant safety issue, the potential for physical injury and discomfort remains.

The recall is the latest in the troubled regulatory history of Ranbaxy, Inc., an Indian corporation.  Ranbaxy, a subsidiary of a Japanese pharmaceutical manufacturer, Daiichi Sankyo, entered into a sweeping consent decree with the U.S. Department of Justice in January 2012 forbidding distribution of atorvastatin in the United States.

Earlier complaints against Ranbaxy, Inc., by the FDA include:

  • Failure to keep accurate records concerning manufacturing compliance
  • Lack of investigation into manufacturing complaints
  • Inadequate maintenance of sterile conditions
  • Inappropriate drug efficacy testing
  • False submission of drug data to the FDA

Describing the consent decree as unprecedented in scope, Ranbaxy is prohibited from manufacturing drugs for the U.S. market at identified facilities until proof of regulatory compliance is provided.

As seen with the current fungal meningitis outbreak, inadequate federal or self-regulation of pharmaceutical companies creates serious safety concerns.  Prevention of these lapses in the creation and compounding of drugs is essential to safeguarding public health.  If a defective product or drug containing a foreign contaminant or other defect injures you, seek reputable legal advice.

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