Glass in Generic Lipitor Pills - Consumer Justice Foundation

Glass in Generic Lipitor Pills

Written by Faith Anderson on December 3, 2012
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Manufacturing Problems at Ranbaxy Facilities

The issue related to the glass particles is only the latest of a series of manufacturing lapses at Ranbaxy, and the company has been operating under a court-ordered consent decree since January. According to federal authorities, a host of manufacturing issues were identified at the company’s plants in India and the United States, and false data was submitted by the firm in drug applications to the FDA. The decree prevents Ranbaxy from producing medications at its most troubled plants until it can prove that it is adhering to U.S. standards, although the company was permitted to continue making products – such as the generic version of Lipitor – at other facilities. According to FDA spokeswoman Sarah Clark-Lynn, the affected lots of generic Lipitor were not manufactured at “the same facilities whose conduct gave rise to the consent decree.”

Oversight of Foreign Manufacturing Plants Criticized

Although the FDA has not yet received any reports of patients being harmed by the glass particles – which are about the size of a grain of sand – some drug manufacturing experts have cited the glass contamination as an example of disparities in the oversight of plants in the United States and those oversees. “I have pretty good faith in companies and plants that make drugs in this country because I know from my own experience that they try to do a good job,” said Prabir K. Basu, executive director of the National Institute for Pharmaceutical Technology and Education. “But my confidence is not that high when we are getting products from outside the country.” According to Basu, research has shown that the FDA inspects foreign generic manufacturing plants only once every seven to 13 years, compared to once every two years for domestic drug manufacturers. A new law passed over the summer however, will eventually require federal drug regulators to apply the same standards when inspecting manufacturing plants, whether they are domestic or foreign.

Contact a Skilled Drug Injury Attorney Today

Ranbaxy has posted information about the recalled lots of generic Lipitor on its website, and has warned that patients should not stop taking the medication without first consulting with their doctor. The lot numbers can be found on the side of the Ranbaxy pill bottles, and the drug company has encouraged patients to contact their pharmacist if they received pills in a container dispensed by a pharmacy. In October 2012, Ranbaxy’s generic Lipitor accounted for 43% of prescriptions for atorvastatin, which is widely used to lower cholesterol in patients across the country. If you believe you have been adversely affected by generic Lipitor or another pharmaceutical drug, contact an experienced drug injury lawyer in your area to discuss your legal options. You may be entitled to financial compensation for your injuries, which you can pursue by filing a drug injury lawsuit against the allegedly negligent manufacturing company.

Posted Under: FDA - Food and Drug Administration
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