Ranbaxy halts production of generic Lipitor; recall second in 3 months

Investigation into glass in raw material found 'quarter-sized' piece missing from machinery
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Ranbaxy Laboratories has halted production of its generic Lipitor while it explores how glass particles got into ingredients used in the pills. The manufacturing glitches that it has had with the atorvastatin appear more complicated than initially suggested when the Indian generics maker ordered a recall last week. It turns out there was an earlier recall three months ago because of possible mispackaged pills that escaped broad public notice.

The two-call pileup is a spoiler for what had seemed like a triumphant return to the U.S. market for what was supposed to be a reformed company, raising questions and lowering the share price for Ranbaxy and its majority owner, Japan's Daiichi Sankyo. The Indian generics maker was selling boatloads of atorvastatin from an Indian plant that is operating under super close scrutiny by outside consultants and the FDA as part of a 5-year consent decree. 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.

The most recent recall is of 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. A notification from the website Prevent Medical Erron 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 it 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 says the danger is small and no problems have been reported. The FDA had sent an alert for this recall but not for the earlier recall. On Aug. 21, 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 90-count bottle. 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."

The FDA said Thursday that Ranbaxy has now put the brakes on production until it gets to the bottom of the problems. The agency says it doesn't foresee a shortage of generic Lipitor 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 41 lots and stopped production.  

- here's the FDA's most recent statement
- read The Wall Street Journal's story
- here's the Prevent Medical Error notification

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