New Delhi: Ranbaxy Laboratories Ltd has stopped production of its generic version of cholesterol lowering drug Lipitor until it investigates the issue of potential glass particles in certain lots, the US Food and Drug Administration (USFDA) has said.
The Indian drug company on 9 November had informed its customers of a voluntary recall of certain lots of the company’s 10mg, 20mg, and 40mg dosage strengths of atorvastatin tablets (generic version of Lipitor), the USFDA said in a statement.
The lots of atorvastatin, packaged in bottles of 90 and 500 tablets, are being recalled due to possible contamination with very small glass particles similar to the size of a grain of sand (less than 1 mm in size), it added.
“Due to this quality issue, Ranbaxy has decided to stop manufacturing atorvastatin until it has thoroughly investigated the cause of the glass particulates and remedied the problem,” the statement said.
Based on the information from Ranbaxy and from the USFDA’s initial assessment, the possibility of adverse events related to the recalled product appear to be low, and if any adverse events are experienced, they would be temporary, the US health regulator noted.
“At this time, we have not received any reports of patient harm due to glass particulates that may be in the recalled product,” it added.
“The USFDA continues to evaluate information associated with this recall and will notify the public as new information becomes available,” USFDA said, adding “Americans expect and deserve safe, effective, and high quality medications.”
The agency will continue to oversee the recall process, and work with the Ranbaxy to resolve these pharmaceutical quality issues, it added.
Shares of Ranbaxy ended down 1.74% at Rs.503.25 on the BSE.
Ranbaxy’s recall of generic version of cholesterol lowering drug Lipitor impacts 41 lots. The recall affects lots which have expiry dates of July 2014 and August 2014.
The Gurgaon-headquartered firm supplies the generic version of Lipitor to the US market from its two facilities—NewBrunswick based Ohm Laboratories and Mohali plant in India.
Ranbaxy had launched generic atorvastatin in the US market in December last year after the USFDA gave final approval to market its generic version of Lipitor produced at Ohm Laboratories facility in New Brunswick, New Jersey.
Ohm Laboratories is a wholly-owned subsidiary of Ranbaxy. In April this year, the company commenced shipping of cholesterol lowering drug, atorvastatin calcium oral tablets from its Mohali SEZ plant in Punjab.
Atorvastatin, the generic equivalent of Pfizer’s Lipitor drug, had generated large sales in the US.