Glass particles found in generic atorvastatin

BMJ 2012; 345 doi: (Published 03 December 2012) Cite this as: BMJ 2012;345:e8236
  1. Edward Davies
  1. 1New York

Ranbaxy Pharmaceuticals has stopped production and issued a recall of its generic version of the cholesterol lowering drug atorvastatin.

The recall applies to certain lots of the company’s 10 mg, 20 mg, and 40 mg tablets. The lots of atorvastatin, packaged in bottles of 90 and 500 tablets, are being recalled because of possible contamination with very small glass particles, similar to the size of a grain of sand (less than 1 mm).

The Food and Drug Administration said, “Based on the information from the manufacturer and from the FDA’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.”1

The latest action came after a smaller recall of atorvastatin in the summer. Ranbaxy recalled one lot containing more than 32 000 bottles of atorvastatin in August after a pharmacist discovered a 20 mg atorvastatin pill inside a bottle of 10 mg pills.

The recall had prompted fears of further drug shortages, but the FDA has said that it did not expect a shortage of atorvastatin. Erin Fox, who tracks drug shortages as director of the Drug Information Service at the University of Utah, told the New York Times that drugs in pill form have long shelf lives and that suppliers could keep large quantities in stock.2

Ranbaxy declined to comment on the situation but has published full details of the recall on its website.3


Cite this as: BMJ 2012;345:e8236


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