Alabama readers may be interested to know that the manufacturer of a generic form of Lipitor is saying that glass particles that may have become embedded in around 480,000 bottles of the drug could have occurred at the company's plant in India. The pharmaceutical company, Ranbaxy Laboratories Ltd., has been criticized the U.S. government for its manufacturing standards, though not specifically for its version of Lipitor.
Ranbaxy alerted the Food and Drug Administration in October that sand-grain-sized pieces of glass had gotten into several sizes of its pills of atorvastatin, which is a generic version of the cholesterol drug Lipitor. After the problem was discovered at the company's U.S. pill manufacturing facility, Ranbaxy voluntarily recalled 480,000 bottles of the 10, 20 and 40 mg. sized pills in the U.S. and halted production as it investigated how the bits of glass got into the medicine.
Now Ranbaxy is beginning to reveal details of that investigation. It says that it believes that the glass lining of a reactor where the drug's main ingredient was made somehow splintered, causing glass to get into the ingredient. The FDA says that it has not received any reports of injury among generic Lipitor users. Ranbaxy says that "not a lot" of consumers in the U.S. received bottles of the recalled lots.
In January, Ranbaxy received criticism from the Justice Department in a consent decree. The agency accused the company of having substandard manufacturing practices and quality control at several of its plants.
People in Alabama who take medications do not want to unknowingly ingest foreign substances like glass that could harm them. Hopefully this incident will not occur again.
Source: The Wall Street Journal, "Ranbaxy Suspects Faulty India Tank in Generic Lipitor Recall," Jonathan D. Rockoff and Peter Loftus, Dec. 5, 2012
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