December 5th, 2012|
December 5, 2012
Three months ago, generic Lipitor was recalled by Ranbaxy because of possible mispackaging. Last week, it was again recalled by Ranbaxy Laboratories, an Indian generics plant, because of glass particles getting into the pills, according to Fierce Pharma.
Forty-one lots of atorvastin (Lipitor) in the 10, 20, and 40 mg sizes have been recalled and production halted. Ranbaxy had about 40 percent of the U.S. market for the drug.
Although the FDA says that the danger is small and no problems have been reported, the website Prevent Medical Error provides more detail than the company or the FDA. It says that Ranbaxy found foreign particles in a “powder” used for making the pills. Then the company discovered a “quarter-sized piece of the glass housing used during manufacturing was found to be missing. It was presumed that this piece of glass fell into the powder during the manufacturing process.”
The FDA said that Ranbaxy has now stopped production until it gets to the bottom of its problems.
In August, the company notified retail customers that it was recalling a single lot of 10 mg atorvastatin after a customer reported finding a 20 mg tablet in a 10 mg bottle. The plant then voluntarily recalled the pills.