Generic Lipitor, atorvastatin calcium, recalled over tiny glass particles

Ranbaxy Pharmaceuticals Inc. is recalling more than 40 lots of atorvastatin pills -- the generic version of the popular statin Lipitor -- over possible glass contamination.

Statins, or lipid-lowering drugs, are among the most commonly prescribed medications in the United States. The drug Lipitor was hugely popular for Pfizer until the company's patent expired in November 2011.

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A generic version of the drug is now being recalled by the India-based Ranbaxy because small glass particles approximately less than 1 millimeter in size may be in select batches, the company said on its U.S. website.

The company's voluntary recall affects certain lot numbers of 10 milligram, 20 milligram and 40 milligram dosage strengths of atorvastatin calcium pills that are packaged in 90- and 500-count bottles. Ranbaxy said the recall is being conducted with knowledge of the U.S. Food and Drug Administration.

A complete list of lot numbers, bottle sizes and dosages can be found on Ranbaxy's website. Patients taking these pills can contact their pharmacy to see if their pills were from affected lots.

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Atorvastatin is prescribed along with diet, exercise, and weight loss to reduce the risk of heart attack and stroke and other cardiovascular ailments in people who have heart disease or who are at risk of developing heart disease.

Ranbaxy Laboratories Limited is India's largest pharmaceutical company, according to its website, and is allied with pharmaceutical Daiichi Sankyo Company Ltd. of Japan.

Reuters reports the company was the first to launch generic Lipitor in the U.S. once Pfizer's patent expired.

"The development will impact the company's credibility to an extent," Bhagwan Singh Chaudhary, a research associate at the brokerage IndiaNivesh, told Reuters. "There have been issues in the past (about compliance) and a recall suggests, corrective measures suggested by the U.S. FDA are not being implemented."

Earlier this year, the FDA and Ranbaxy settled an ongoing legal battle over questionable manufacturing practices and "data integrity issues" at several of the company's Indian facilities and one located in New York State. A consent decree was filed by the U.S. Department of Justice on behalf of the FDA in which the drug manufacturer agreed to remedy these problems.

"Because this company continued to violate current good manufacturing practice regulations and falsify information on drug applications, the FDA took these actions in an effort to protect consumers," Dara Corrigan, FDA associate commissioner for regulatory affairs, said in a January 25, 2012 statement. "The FDA continues to be committed to protecting consumers from potentially unsafe products that may be offered on the market."

[Bigfrank306]

Be careful out there! I picked up a prescription for Atorvastatin at my local CVS in Woodstock, VA yesterday (11/27) and just through luck came across this report. I called the pharmacy and asked about the recall and was more or less blown off, they told me that that was an old recall (even though the recall only happened 5 days before) and was then told that my prescription was from a different manufacturer anyway. Something did'nt add up, so I looked a little closer at the precrition label and found in super small print "Ranbaxy Pharmac". They had told me different manufacturer, so I looked a little deeper, found the lot numbers on Ranbaxy's website. Guess what, the lot number on my bottle matches. This prescrition ahd been filled on 11/15 and sat in their bins until I picked it up on 11/27 (was an auto refill I was unaware of). No calls that I might have a contaminated prescrition and in fact incorrect information when I did call. Just one more reason that the cost pressure by insurance companies to force people to generic drugs is not in our best interest.

[seniorstylist21]

my husband works for a labor union,as a member you may only use Medco now express-scripts.Ijust took my 20mg's of atorvastatin by Ranbaxy.Why you think I'd get call from member services,warning me of possible contamination.Also my mother took thalidamide for vomiting during pregnancy(with me),lucky for us she threw up her 1st.dose,never took anymore,now I have my arms and legs.the legs are another tragic story involving a motorcycle,which is why I take at least half of my 11 meds.from India apparently.Glad I read this blog tonight.Thanks again Mmo, for the phonecall.

[blapaglia]

Seniorstylist21, are you saying you did you get a phone call because I have the same prescription provider and I haven't heard anything. Did they say only that it was possibly contaminated and offer to send another bottle of pills? Thanks.

[asikhs]

Manufacturing problems in the drug industry are not limited to generics or India.

[donpantanella]

The FDA is a joke. They rubber stamp drug approvel from places like India knowing that companies like Ranbaxy are not to be trusted.

[R-U-Serious]

Oh no, I take lipitor and use Medco does anyone know if Medco is aka Express Scripts also?

[Filmguy870]

YUP...Medco = Express Scripts.

[cheapster512]

I was wondering how IT cut my cholestoral down TINY pieces of glass who knew? slice and dice drug

[hypnotoad72]

Yup. We can't import from Canada because it's "too dangerous", yet these Chinese and Indian companies put out contaminated methotrexate or glass in atorvastatin and it's A-OK...

Here's Ranbaxy's "mission" statement:
"Ranbaxy is to provide value through pioneering work, research & development and quality pharmaceuticals across the globe."

Yeah. Glass is real value...

so if you think regulations are bad, keep voting for this. Just get everyone else to swallow it instead.

[mahakavinow]

Anytime a medicine recall is announced it creates a little panic because it is something we consume to treat an illness and we don't want any danger from either contaminated medication or extraneous material in the medication. Recalls are not limited to those manufactured in foreign soils. Even those medicines (proprietary) manufactured in the US have been recalled. Google lipitor recall by Pfizer. It does not matter where the medicine is manufactured. Let FDA have the proper authority to have good oversight.

[hypnotoad72]

That's technically true as well, and it did cross my mind there have been recalls about meds made in the US as well.

[taxed01]

Never saw anything about anybody wanting to get rid of the FDA.

[mahakavinow]

The Republicans don't clamor for getting rid of FDA for sure. But they want FDA to approve more drugs submitted as NDA and also on an accelerated basis. They do not pay attention to the haphazard manner in which the drug companies submit the clinical research data. Many times the drug companies submit less than clear-cut data hoping to slide through the FDA doors. FDA does not want to block drugs which have a clean bill of health. They would like to err on the side of caution. Despite such caution several drugs have huge problems with severe side effects (Avandia is an example in point).So it behooves the drug companies to be honest in submitting the clean data and not take chances with their submissions.

[hypnotoad72]

Well, we know some people are anti-regulation, anti-FDA, and pro-"free market".

THAT is why those comments were injected. As a preemptive measure, but it's nice you paid attention - even as tangentially as he posted his segue...

[saucymugwump]

And don't forget, Republicans want to eliminate the FDA and many other government agencies because of their belief in the fairy tale that the market will regulate itself. If you want to learn about how the FDA prevented one of the more dangerous drugs from entering the country in the 1960s, search on "fda thalidomide" to discover how Dr. Frances Kelsey prevented a human disaster in the USA.

King Soopers and other grocery chains sell generic painkillers, e.g. aceteminophen, which are manufactured in India. Check the label the next time you buy generic painkillers.

Express Scripts, a company established to provide prescription drugs for 90-day plans, exclusively uses Ranbaxy and Dr. Reddy's, both large Indian manufacturers, for generic drugs.

[hypnotoad72]

Well said, thank you.

The market would sell its own mother to make a profit as well.

[donpantanella]

Very good idea, replace the FDA with someone who cares what poison drugs are being allowed in this country. The FDA knows very well how bad a company Ranbaxy is but continues to rubber stamp them for drug approval.