Ranbaxy Laboratories is trying to determine if a missing fragment of glass from a shield of a piece of machinery at a plant in India is the source of the problem that has caused it to halt production on its lucrative generic Lipitor product.
The Indian generics maker, which is operating under a 5-year consent decree with federal regulators, at first recalled 41 lots of atorvastatin in the 10 mg, 20 mg and 40 mg sizes because of a chance that small particles of glass could have gotten into some of the pills. But last week, it said it would hold up production until it got to the bottom of the problem.
A notification from the website Prevent Medical Error provides more detail than the company or the FDA has so far. It says Ranbaxy found foreign particles in a "powder" used for making the pills. When Ranbaxy tracked it back, it 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 late last week sent out another notification assuring consumers and healthcare providers that the risk from any minuscule particles would be extremely low and pointing out that not all of the atorvastatin Ranbaxy is making is affected by the recall. It also said there should be no shortage related to the recall because there are other producers of the generic, namely Mylan ($MYL) and Watson Pharmaceuticals ($WPI). Ranbaxy had about 40% of the U.S. market for the drug, The Wall Street Journal points out, at least before it recalled the 41 lots and stopped production.
The Indian generics maker, which is controlled by Japan's Daiichi Sankyo, was selling boatloads of atorvastatin from an Indian plant that is operating under super close scrutiny by outside consultants and the FDA. The company was nailed for a plethora of manufacturing and reporting problems it was found to have. And it is possible that the recalls actually reflect tighter quality control and greater caution at the drugmaker, although so far, Ranbaxy has not had much to say about the problems.
It turns out, the company in August also had recalled a single lot of atorvastatin when a retail customer reported finding a 20 mg tablet in a 90-count bottle of 10 mg pills. Ranbaxy said in a letter that it voluntarily recalled the pills because its investigation had not "been able to rule out the possibility of this occurring at our facility."