Drug major Ranbaxy Laboratories has recalled over 64,000 bottles of Atorvastatin calcium tablets, a generic version of cholesterol-lowering drug Lipitor, after a complaint of wrong dosage.
The Indian firm, which is reeling under regulatory action from the US Food and Drug Administration (USFDA), recalled the drug after a complaint by a pharmacist who discovered a 20 mg tablet inside a sealed bottle of Atorvastatin 10 mg tablets.
“Ranbaxy Pharmaceuticals is conducting a voluntary recall in the US limited to two lots of Atorvastatin calcium tablets, 10 mg manufactured in India which expire in May 2014,” it said in a statement.
The company, majority owned by Japan’s Daiichi Sankyo, said it recalled the tablets “because of a remote possibility of the presence of a 20 mg Atorvastatin calcium tablet in a 10 mg bottle.”
“This is the basis of the voluntary recall,” it added.
To date, Ranbaxy has not received any product complaints related to these batches, the company said.
“Other lot numbers, package sizes and strengths are not affected by this recall. The recall is being conducted at the retail level,” it added.
Ranbaxy is withdrawing the lots out of abundant caution, keeping the safety of patients in mind and with full knowledge of the USFDA, it said.
In January, the USFDA prohibited Ranbaxy from producing and distributing drugs for the American market from its Toansa facility in Punjab.
The Toansa plant catered to over 70 per cent of Ranbaxy’s requirement for raw material used in medicine formulations.
Toansa was the fourth Ranbaxy plant banned by the USFDA.
In September, the USFDA imposed an import alert on Ranbaxy’s Mohali plant in Punjab for violating good manufacturing norms.
Ranbaxy’s key facilities at Paonta Sahib in Himachal Pradesh and Dewas in Madhya Pradesh have been under a US import alert since 2008.