A few weeks after it recalled certain contaminated lots in the USA of generic atorvastatin, Ranbaxy Laboratories has now stopped manufacturing its copy of Pfizer's cholesterol-lowerer blockbuster Lipitor as it gets to the bottom of the problem.
Last month, the Indian drugmaker announced a recall of some of its generic Lipitor which affected 10mg 20mg and 40mg dosage strengths, packaged in 90 and 500 count-bottles. The move was prompted after some batches were identified that may contain a foreign substance, ie small glass particles less than 1mm in size, and the recall does not include atorvastatin 80mg.
Now Ranbaxy has decided to halt production of generic atorvastatin until it has completed a full investigation into the problem. The US Food and Drug Administration issued a statement saying it "has determined that the possibility of adverse health problems related to the recalled atorvastatin is extremely low".
To date, the agency added that has not received any reports of injury, saying it will "continue to oversee the recall process and work with Ranbaxy to resolve quality issues". The FDA went on to say it does not anticipate a drug shortage but is working with other atorvastatin manufacturers to avoid such a scenario and "is closely monitoring the situation"._
Nevertheless, having to cease manufacturing again puts the spotlight on Ranbaxy's capabilities and echoes its previous problems with the FDA over manufacturing violations discovered in 2009 at its Dewas and Paonta Sahib plants, a dispute that was only resolved this year.