CardioExchange Archive

CardioExchange, an NEJM practice community for medical professionals dedicated to improving cardiac patient care, was active from 2009 to 2015. CardioExchange fostered discussion between clinicians from across the globe.

November 29th, 2012

Following Earlier Recall, Ranbaxy Halts Manufacturing of Atorvastatin

Ranbaxy, the often-troubled manufacturer of generic drugs, will temporarily stop manufacturing generic atorvastatin. On November 9, 2012, the company announced a voluntary recall of some lots of atorvastatin because of possible contamination with glass particles. An FDA statement today said that Ranbaxy will discontinue making the drug “until it has thoroughly investigated the cause of the glass particulates and remedied the problem.”

To date, no reports of harm from the contamination have been received by the FDA. Both FDA and Ranbaxy believe there is only a low likelihood that there will be adverse events related to the problem.

The FDA said it does not anticipate a shortage of atorvastatin because of the recall, but that it “is working with other manufacturers of atorvastatin to ensure adequate market supply.”

Categories: Prevention
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3 Responses to “Following Earlier Recall, Ranbaxy Halts Manufacturing of Atorvastatin”

  1. Harlan M. Krumholz, MD, SM says:
    November 29, 2012 at 2:07 pm

    The news that Ranbaxy is temporarily ceasing production of atorvastatin is good news/bad news. The good news is that the FDA oversight has detected issues that are sufficient to have them discontinue. We should feel good that the FDA was able to intervene early and has a system in place to evaluate generic drug production. The bad news is that Ranbaxy had this problem – and that generic production of atorvastatin is being stopped by them – and that confidence in generics are likely to decline.

    • David Kaufman, MD says:
      December 7, 2012 at 10:43 pm

      I wish I could feel as good about the FDA. They may have detected the problem and issued a recall and shut down the factory. But amazingly, they have told the PBMs, Medco specifically, that there is no need to replace drug or recall it, because of “low”likelihood of problems. Very reassuring. They stop production because of glass in the pills but don’t feel the need to order Medco et al to send out replacement drug. I spoke directly to Medco and that is what they told me. They refused to replace drug saying “low likelihood’ of problems. Imagine, just imagine, what the malpractice lawyers would say if you or I did something like that!!! If the FDA thought there was a systemic problem–they ordered the factory shut down–they should have ordered the PBMs to replace med.

  2. Anil Virmani, MD, DRM says:
    December 3, 2012 at 10:53 pm

    This only goes to prove that when you ask pharma companies to “also” produce generic medicines at low cost along with the branded medicine of the same molecule, quality control is bound to suffer ! After all it is the company’s bottom-line that matters !