Ranbaxy recalls Generic Lipitor in US due to dose mix-up
Ranbaxy Laboratories has recalled over 64,000 bottles of the generic version of its cholesterol lowering drug in US. The Company recalled tablets of atorvastatin calcium, the generic name for Lipitor's active ingredient, after a pharmacist found a 20 mg tablet in a sealed bottle marked for 10 mg tablets, the US FDA said on its website.
The FDA classified the recall as Class II, which is reserved for situations in which a product may cause temporary or medically reversible health problems, or where the probability of a serious health problem is remote. This is the third recall of the same drug over the past two years. The company had recalled 480,000 bottles of the cholesterol lowering medicine in November, 2012 after it discovered contamination with tiny glass particles. This recall instigated Ranbaxy to suspend production while it fixed the problem; the company resumed production last year. The newly recalled bottles were distributed in 2012 and have expiration dates of May 2014.
A Ranbaxy spokesman said that the company hasn't received any complaints about the recalled batches and the recall is being conducted at the retail level. The company 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.