2012年1月9日星期一

Novartis is the most recent company to suffer from production problems

Novartis is recalling 1,645 lots of its Excedrin, NoDoz, Bufferin and Gas-X medicines because the products could contain stray capsules moncler jackets or caplets from other products, or "contain broken or chipped tablets."

The plant in Lincoln, Neb., where the products are manufactured was shut down last month. The plant also makes some opioid prescription painkillers for Endo Pharmaceuticals Holdings Inc., including Opana, Percocet and an extended-release version of morphine tablets.

Both Novartis and the FDA said they weren't aware of any adverse events in patients from any mix-ups. Novartis said it was offering customers a refund.

Novartis is the most recent company to suffer from production problems. Just last month Johnson & Johnson's McNeil Consumer Healthcare unit recalled 12 million bottles of Motrin, saying some pills may not dissolve as quickly as intended. That company has been plagued by manufacturing quality problems since 2009 and has dozens of product recalls including Tylenol and Benadryl.

However, "given existing inventories, Moncler Men Vest - Cheap Moncler Jackets the expected restart of Novartis production and our ability to shift production to other facilities we believe the supply constraints of our products should be limited," said Julie McHugh, the company's chief operating officer.

Novartis said it would take a charge estimated at $120 million in the fourth quarter of 2011 related to the recalls and the work needed to fix the Lincoln facility.

"We are committed to a single quality standard for the entire Novartis Group and we are making the necessary investments and committing the right resources to ensure these are implemented across our entire network," Joseph Jimenez, the Swiss company's chief executive, said.

Edward Cox, a director in FDA's office of new drugs, said there's a potential for tablets to be retained in a machine involved in the product packaging process but said the FDA couldn't comment further on the ongoing investigation into the plant's problems.

Mr. Cox said the agency opted against asking for a recall of Endo's prescription pain products because the potential for drug mix ups appeared to be low and pharmacists can screen for any problems before the pain pills reach consumers. He said there's been three reports of mix-ups since 2009 that were caught by pharmacists. Endo cheap moncler jackets on Monday said there may be a short-term disruption in the supply of some of its pain products and recommended that doctors refrain from starting new patients on the extended-release version of Opana to preserve supply for existing patients.

A July inspection report released by the FDA cited several consumer complaints of certain formulations of Excedrin being mixed up. For example some consumers said they found Excedrin Migraine Tablets being mixed with Excedrin Migraine caplets or geltabs.The agency said Novartis failed to adequately investigate 166 complaints related to "foreign tablets in your drug products since 2009."

Specifically Novartis is recalling three types of Bufferin, an aspirin product, and Gas-X Prevention, a food-enzyme supplement, with expiration dates of Dec. 20, 2013 or earlier. The company is recalling certain bottle sizes cheap moncler of its pain medicine Excedrin and NoDoz products with expiration dates of Dec. 20, 2014 or earlier. NoDoz contains caffeine and is marketed as an alertness product.

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