In the latest of a series of quality concerns, Ranbaxy Laboratories has recalled more than 64,000 bottles in the USA of its generic version of Pfizer’s cholesterol blockbuster Lipitor.
The Indian drugmaker has voluntarily recalled atorvastatin tablets after a pharmacist found a 20mg tablet in a sealed bottle marked as 10mg, the US Food and Drug Administration noted on its website. The FDA declared the recall as Class II, defined by the agency as “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote”.
Reuters received a statement from the company saying that “Ranbaxy is proactively recalling the lots out of an abundance of caution, keeping the safety of its patients in mind and with the full knowledge of the FDA”.
The recall is the latest in a long line of quality control problems to hit Ranbaxy or indeed its Lipitor copy. In November 2012, it recalled certain lots of the drug which had been contaminated with small glass particles; production in the USA resumed in February last year.
In January this year, the FDA added a fourth Indian facility run by Ranbax, to the list of sites prohibited from manufacturing and distributing active pharmaceutical ingredients for the US market.
