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Novartis Warns Of Wrong Tablets In Pet Medicine Clomicalm Bottles

1/31/2012 6:38 AM ET

It's been only a few days since the consumer health division of Swiss drug maker Novartis AG (NVS: Quote) temporarily suspended operations at Lincoln, Nebraska, production facility and recalled certain over-the-counter drugs - Bufferin, Excedrin, Gas-X Prevention and NoDoz, due to mix-up of products. Now, the animal health division of Novartis has warned that a wrong tablet may be found in bottles of Clomicalm, which is prescribed to treat behavioral disorders in dogs.

Novartis Consumer Health Inc., the consumer health division of Novartis, initiated the voluntary recall of the OTC drugs on January 8, following consumer complaints of chipped and broken pills in the products and inconsistent bottle packaging line clearance practices.

The opiate products manufactured and packaged for Endo Pharmaceuticals Holdings Inc. (ENDP) by Novartis Consumer Health at the Lincoln, Nebraska manufacturing site have also been put on alert for a potential product mix-up.

However, there have been no reports of related adverse events as a result of these issues.

On January 25, Novartis Animal Health US, Inc. warned that due to potential packaging issues at its manufacturing facility, there is a rare possibility that a wrong tablet may be found in bottles of Clomicalm. The animal health unit of Novartis said that it has not received any reports where a patient experienced a product mix-up, or any reports of adverse events attributable to a product mix-up.

As a precautionary measure, Novartis is recommending that before dispensing Clomicalm, the contents of the bottle should be examined for tablets that are broken or incorrect in color, shape or size.

On January 10, Novartis had already warned that the temporary suspension of operations at the Lincoln, Nebraska, production facility would affect the availability of some Novartis Animal Health products for the immediate future. The manufacturing plant produces both OTC and animal health products.

The animal health products affected include, Interceptor Flavor Tabs, Sentinel Flavor Tabs, Clomicalm, Program Tablets and Suspension, and Milbemite. Production of Deramaxx, which was recently moved to the site, is also affected, although supplies on hand will continue to be shipped, according to the letter sent by Novartis to the veterinary community.

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by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

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