The recall affects Ranbaxy’s 10 mg, 20 mg and 40 mg dosage strengths, packaged in 90’s and 500 count bottles. The recall is being conducted for certain batches that may contain a foreign substance (small glass particles approximately less than 1 mm in size).

Ranbaxy states that this recall is a precautionary measure in order to ensure the safety of customers and is being conducted with the full knowledge of FDA. The generics giant adds that the recall only affects certain lot numbers of its generic atorvastatin and that it does not affect or relate to the 80 mg strength.

The recall is a major blow for Ranbaxy, who launched its generic atorvastatin in the US on 1 December 2012, after finally gaining FDA approval, despite much speculation as to whether the generics giant would be ready in time due to problems at its Dewas and Paonta Sahib manufacturing plants [1]. Ranbaxy is also subject to a consent decree from FDA, which reportedly cost the company US$500 million, and cost the company certain generics exclusivities, in order to solve the company’s outstanding regulatory problems [2].

The news is also not good for patients. It is estimated that one million prescriptions a week are written in the US for generic Lipitor, and Ranbaxy is the biggest supplier of the drug. This had led to fears that the recall may lead to a shortage of generic Lipitor in the US, according to Ms Stephanie Yao, a spokeswoman for FDA, although the agency is working with other drugmakers to help fill the void in supply.

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Reference

1.  GaBI Online - Generics and Biosimilars Initiative. Ranbaxy gets FDA approval and launches generic atorvastatin [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 November 30]. Available from: www.gabionline.net/Generics/News/Ranbaxy-gets-FDA-approval-and-launches-generic-atorvastatin

2.  GaBI Online - Generics and Biosimilars Initiative. Ranbaxy consent decree with FDA submitted to court [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 November 30]. Available from: www.gabionline.net/Generics/News/Ranbaxy-consent-decree-with-FDA-submitted-to-court

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