In November 2012, Ranbaxy Pharmaceuticals, the US subsidiary of Ranbaxy, voluntarily recalled 41 batches of its atorvastatin calcium tablets, the generic version of Pfizer’s Lipitor, from the US market due to the presence of foreign particles (small glass particles less than 1 mm in size) [1].

Although FDA stated that the ‘possibility of adverse health problems related to the recalled atorvastatin [was] extremely low’, the recall, which affected the 10 mg, 20 mg and 40 mg dosage strengths of atorvastatin, was followed by a decision to halt production altogether until a full investigation was completed.

Since then, some consumers have sued Ranbaxy, claiming they suffered gastrointestinal problems after taking the drug. One patient claimed it caused internal bleeding and holes in her stomach. Ranbaxy dismissed the complaints as not credible and FDA said it has not received any reports of adverse events related to the glass particles in the pills.

In a statement Ranbaxy said that the company has been working with FDA to implement multiple corrective and preventive actions, which have led to this restart in the production of generic atorvastatin. The company also pointed out that initiating the manufacturing process for generic atorvastatin was the first step toward resuming supplies to the US market.

Ranbaxy also highlighted that this recall did not affect atorvastatin calcium tablets or any other product containing this molecule distributed outside the US, and that it remains confident in the continuing safety and quality of the drug products delivered to all of its customers worldwide.

Related articles

First generic atorvastatin launched in Australia and Europe

Ranbaxy consent decree with FDA submitted to court

Ranbaxy gets FDA approval and launches generic atorvastatin

Reference

1.  GaBI Online - Generics and Biosimilars Initiative. Ranbaxy recalls generic atorvastatin in US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Mar 1]. Available from: www.gabionline.net/Generics/News/Ranbaxy-recalls-generic-atorvastatin-in-US

Permission granted to reproduce for personal and educational use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.