Last week Reuters, Bloomberg, the Washington Post and the Economic Times all reported that Ranbaxy had pulled 64,000 bottles of generic Lipitor over concerns some of the pills may be double strength.
What the reports did not say is that the recall took place in January.
The media coverage came a few days after the US Food and Drug Administration (FDA) detailed the recall in an enforcement report published on March 5.
In the report the agency makes clear that the product withdrawal was initiated by Ranbaxy as a precautionary measure on January 16.
This was confirmed by Ranbaxy spokesman Krishnan Ramalingam who told in-Pharmatechnologist.com “The actual recall happened in January, 2014” and provided the following statement issued by the firm at the time.
“Ranbaxy Pharmaceuticals Inc. is conducting a voluntary recall in the US limited to two lots of Atorvastatin calcium tablets, 10 mg manufactured in India: (Lot # 2407255 and 2407256) which expire in May, 2014.
“Because of a remote possibility of the presence of a 20mg Atorvastatin calcium tablet in a 10mg bottle, this is the basis of the voluntary recall. To date, Ranbaxy has not received any product complaints related to these batches. Other lot numbers, package sizes and strengths are not affected by this recall. The recall is being conducted at the retail level.”
Ramalingam also told us the firm “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 US FDA.”
Timing
Last week’s reports of the January recall come amid growing US concerns about the quality of drugs and active pharmaceutical ingredients (APIs) made in India and follow hot on the heels of FDA commissioner Margaret Hamburg’s visit to the country.
The US FDA does not publish enforcement reports until a recall has been classified. The Ranbaxy measure has been assigned class II status, which is applied to “products that might cause a temporary health problem, or pose only a slight threat of a serious nature”
Ranbaxy - which is operating under a consent decree and banned from exporting to the US from several of its Indian facilities - is often citied in reports expressing concerns about the quality of drugs made in India.