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Patty
11-10-2010, 03:28 PM
I went looking for Ali's shampoos we've used for quite some time and just learned they are not currently being manufactured. These reports are dated '09.

I'd asked my vet's office if they could order them for me and their distributor told them the product line had been sold to another company. I've not found this to be the case yet in searching the internet. We use Hylyt and Malaseb shampoos. The distributor told them that Demezole and Allermyl were the new products. The ingredients however are not the same. Bad news for my allergic girl.

News releases to follow...

Patty
11-10-2010, 03:29 PM
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm174880.htm

FDA NEWS RELEASE

For Immediate Release: July 31, 2009
Media Inquiries: Michael Herndon, 301-796-4673, michael.herndon@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA Takes Action Against Teva Animal Health Inc.
Company fails to adhere to current Good Manufacturing Practice regulations

The U.S. Food and Drug Administration announced a consent decree of permanent injunction filed today, that prohibits Teva Animal Health Inc., its president, and two principals from its parent company, from manufacturing and distributing adulterated veterinary drugs. The injunction, once entered by the court, will prevent the defendants from manufacturing and distributing veterinary drugs until they achieve compliance with current Good Manufacturing Practice (cGMP) and obtain FDA approval.
“Good manufacturing practice standards are the backbone of product quality and the instrument on which the FDA relies most heavily for assurance that veterinary drug products are safe and effective,” said Bernadette Dunham, D.V.M., Ph.D., director of the FDA’s Center for Veterinary Medicine.
During inspections between 2007 and 2009, the FDA found significant cGMP violations at Teva Animal Health's facilities, located in St. Joseph, Mo.
Under the terms of the consent decree, Teva Animal Health cannot resume manufacturing and distributing veterinary drugs until adequate methods, facilities, and controls are established and an independent expert inspects the facilities and procedures and certifies that they comply with cGMP. The FDA also will also inspect Teva Animal Health's facilities as needed before authorizing the company to resume operations. If, after resuming operations, the defendants fail to comply with any provision of the consent decree, cGMP, or the Federal Food, Drug, and Cosmetic Act, the FDA may order the company to stop manufacturing and distributing veterinary drugs, recall the products, or take other corrective actions.
“The FDA will not tolerate the manufacture and distribution of adulterated animal drugs,” said Michael Chappell, the FDA’s acting associate commissioner for regulatory affairs. “Veterinarians and pet owners can be assured that the FDA will investigate and take regulatory actions against companies that produce animal drugs under conditions and controls that are inadequate to assure their safety and quality.”
In the event of future violations, the consent decree also subjects Teva Animal Health to payments of $20,000 for each day the defendants fail to comply with any provision of the decree and an additional $25,000 for each shipment of veterinary drugs in violation of the decree, up to $7.5 million per year.

Patty
11-10-2010, 03:29 PM
http://news.vin.com/VINNews.aspx?articleId=13539

Teva Animal Health closes shop
August 3, 2009
By: Jennifer Fiala
For The VIN News Service

Teva Animal Health has stopped manufacturing generics and its DVM Pharmaceuticals line of products following a crackdown by the U.S. Food and Drug Administration (FDA) on the company’s quality control practices.

“We have no additional information to provide at this time, but will keep our customers apprised of the situation as we have news to share,” says Denise Bradley, senior director of Teva’s North America Corporate Communications.

Members of the Veterinary Information Network (VIN) report (http://www.k9diabetes.com/Link.plx?ID=76838) that some Teva Animal Health products are on backorder. The company (http://www.k9diabetes.com/Link.plx?ID=76834) is commonly known for its medicated shampoos and skincare products, as well as supplements.

In an e-mail to the VIN News Service, Bradley adds the following prepared statement:

“Teva Animal Health regrets the deficiencies in our manufacturing practices, and we have already initiated corrective actions to ensure that we will swiftly meet all regulatory requirements. These actions include conducting a complete analysis of each individual product; retraining all of our production employees, and revalidating our equipment, processes and methods.”

Teva’s efforts are in response to a lawsuit filed by FDA on July 31 in U.S. District Court, suing Teva Animal Health, as well as the regulatory agency’s move last Friday to shut down (http://www.k9diabetes.com/Link.plx?ID=76839) the company’s Missouri plant. An injunction prohibits the company from manufacturing and distributing adulterated veterinary drugs.

FDA alleges that three regulatory inspectors documented “numerous” Good Manufacturing Practice violations.

Other FDA complaints (http://www.k9diabetes.com/Link.plx?ID=76840) include a reported failure by the company to establish a quality control unit, provide adequate employee training, conduct adequate equipment maintenance and reject drug products that failed to meet quality specifications.

Teva Animal Health (http://www.k9diabetes.com/Link.plx?ID=76835) is an arm of Israeli-based Teva Pharmaceutical Industries Ltd. It was born in January 2006, when Teva Pharmaceuticals acquired IVAX Corp., its subsidiary, IVX Animal Health. IVX Animal Health is comprised of Phoenix Science Inc., the largest manufacturer of generic pharmaceuticals for the U.S. animal-health market, and DVM Pharmaceuticals, a specialty veterinary pharmaceutical company focusing on topical dermatologicals and nutraceuticals for pets, which had merged in 2005 under the IVX Animal Health name.

“The FDA will not tolerate the manufacture and distribution of adulterated animal drugs,” says Michael Chappell, the FDA’s acting associate commissioner for regulatory affairs, in a news release. “Veterinarians and pet owners can be assured that the FDA will investigate and take regulatory actions against companies that produce animal drugs under conditions and controls that are inadequate to assure their safety and quality.”

Earlier this month, Teva Pharmaceuticals voluntarily recalled (http://www.k9diabetes.com/Link.plx?ID=76841) two lots of the anesthetic propofol following a federal government investigation of recent cases of nonrespiratory febrile reactions among human patients undergoing endoscopy in the United States.

Teva’s Bradley insists that the incident is not connected to FDA’s actions against Teva Animal Health.

According to the lawsuit’s consent decree, future violations will cost the company $20,000 for each day that Teva fails to comply with any provision of the decree and an additional $25,000 for each shipment of veterinary drugs in violation of the decree, up to $7.5 million per year.