Ranbaxy recalls generic Lipitor doses for glass shards
Ranbaxy Pharmaceuticals Inc. has recalled dozens of lots of its generic version of the cholesterol drug Lipitor because some may contain tiny glass particles, the latest in a string of manufacturing deficiencies that once led regulators to bar imports of the Indian company's medicines.
Ranbaxy, a subsidiary of Ranbaxy Laboratories Ltd., India's biggest drug maker, is operating under increased scrutiny from the U.S. Food and Drug Administration because of quality lapses at multiple Ranbaxy factories over the past several years.
The FDA also has alleged the company lied about test results for more than two dozen of its generic drugs several years ago.
On Friday, Ranbaxy posted a notice on its U.S. website, saying it's recalling 10-, 20- and 40-milligram doses of tablets of atorvastatin calcium. That's generic Lipitor, the cholesterol fighter that reigned for years as the world's top-selling drug.
The recall includes 41 lots of the drug, nearly all with 90 pills per bottle, but three lots contain 500 pills per bottle. It's unclear how many bottles are in each lot, but medicine batches typically contain many thousands of pills.
The 80-milligram strength tablets are not affected.
Ranbaxy spokesman Chuck Caprariello did not answer questions or provide any additional information beyond the statement on the company's website.
“Ranbaxy is proactively recalling the drug product lots out of an abundance of caution,” the website statement read. “This recall is being conducted with the full knowledge of the U.S. FDA.”
Ranbaxy's lead in the generic Lipitor market may be at risk from the recalls, according to a report by Bloomberg Industries. Mylan Inc. of Canonsburg and Watson Pharmaceuticals Inc. could take market share from Ranbaxy, the report said.
The company also filed a two-sentence statement with the Bombay Stock Exchange stating Ranbaxy's investigation would be completed within two weeks, but that after the temporary disruption to the U.S. supply, the company expected to resume shipments here.
Patients who have filled a prescription can contact their pharmacy to determine whether it was made by Ranbaxy or another generic drug maker, and if it's from Ranbaxy, whether it came from a recalled lot.
Ranbaxy's manufacturing deficiencies, dating to 2006, led to a lengthy investigation and sanctions by the FDA. During the probe, federal investigators found Ranbaxy did not properly test the shelf life and other safety factors of its drugs and then lied about the results.
In mid-2008, the FDA barred Ranbaxy from shipping into the United States more than 30 different drugs made at factories in India. Meanwhile, the Department of Justice demanded Ranbaxy turn over internal documents, alleging the company lied about ingredients and formulations of some medications.
In early 2009, the FDA said it would not consider any new applications from Ranbaxy to sell in the United States any products made at the troubled factories.
As FDA discussions with Ranbaxy continued, it appeared the company would lose its shot at a revenue windfall when Lipitor's generic U.S. patent expired last Nov. 30. At the time, Lipitor brought in almost $8 billion a year in U.S. sales.
As often happens when patents expire, for the first six months only one generic rival could compete with brand-name Lipitor. Ranbaxy had that right, although an authorized generic from Lipitor maker Pfizer Inc. and partner Watson Pharmaceuticals went on sale on Dec. 1. With competition so limited, the generic prices declined only a bit from the brand-name drug's price of about $115 a month — until several other generics entered the market six months later.
The FDA finally ended the suspense, deciding just before midnight Nov. 30 to let Ranbaxy sell generic Lipitor made at the company's Ohm Laboratories factory in New Jersey.
It was unclear Friday whether the recalled Ranbaxy pills were made there or elsewhere.
Meanwhile, Ranbaxy is operating under a settlement with the FDA, called a consent decree, signed on Dec. 20, 2011. It requires Ranbaxy to improve manufacturing procedures, ensure data on its products is accurate and undergo extra oversight and review by an independent third party for five years. Ranbaxy at the time set aside $500 million to cover potential criminal and civil liability stemming from the Justice Department investigation.
Show commenting policy
TribLive commenting policy
You are solely responsible for your comments and by using TribLive.com you agree to our Terms of Service.
We moderate comments. Our goal is to provide substantive commentary for a general readership. By screening submissions, we provide a space where readers can share intelligent and informed commentary that enhances the quality of our news and information.
While most comments will be posted if they are on-topic and not abusive, moderating decisions are subjective. We will make them as carefully and consistently as we can. Because of the volume of reader comments, we cannot review individual moderation decisions with readers.
We value thoughtful comments representing a range of views that make their point quickly and politely. We make an effort to protect discussions from repeated comments either by the same reader or different readers.
We follow the same standards for taste as the daily newspaper. A few things we won't tolerate: personal attacks, obscenity, vulgarity, profanity (including expletives and letters followed by dashes), commercial promotion, impersonations, incoherence, proselytizing and SHOUTING. Don't include URLs to Web sites.
We do not edit comments. They are either approved or deleted. We reserve the right to edit a comment that is quoted or excerpted in an article. In this case, we may fix spelling and punctuation.
We welcome strong opinions and criticism of our work, but we don't want comments to become bogged down with discussions of our policies and we will moderate accordingly.
We appreciate it when readers and people quoted in articles or blog posts point out errors of fact or emphasis and will investigate all assertions. But these suggestions should be sent via e-mail. To avoid distracting other readers, we won't publish comments that suggest a correction. Instead, corrections will be made in a blog post or in an article.
- U.S. Steel shares jump on turnaround strategy
- Bayer plastics unit may be gone
- Investors applaud central bank’s decision
- Fed not budging on rate increase
- Consol, Noble expect at least $325 million from partnership’s IPO
- Experts say economic edge at stake with R&D tax credits
- UPMC buying New Castle-based Jameson Health System
- Mylan CEO Bresch sets sights on growth
- 2 top executives at Dick’s Sporting Goods to retire
- Douglas Laboratories sells Klean Athlete: products free from banned substances
- Mylan cuts ties with NFL star charged with child abuse