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Potential Packaging Issues With Clomicalm

By Kimberly Porter    February 03, 2012 at 03:34PM / (0) comments

A Novartis manufacturing plant in Lincoln, Nebraska, has been voluntarily shut down while the company addresses quality control issues. The U.S. Food and Drug Administration (FDA) issued a critical report of the plant last June, after Novartis failed to address consumer complaints about mix-ups between different medications. Clomicalm, a pet medication used to treat separation anxiety disorder in dogs, is potentially affected.

Clomicalm is packaged on a shared packaging line where certain recalled over-the-counter products (OTC), such as Excedrin, NoDos, Bufferin, and Gas-X, are also packaged. There were reports of powerful prescription medications being mixed in with the OTC products during packaging.

While Clomicalm has not been recalled, a letter was sent out to veterinarians warning them of this potential issue, though no reports of mix-ups in Clomicalm have been received. The letter stated the following precautionary measures should be taken:

 

  1. Carefully examine the tablets in your pet’s prescription bottle. If you are not sure how Clomicalm should look, please visit www.petwellness.com/clomicalm. The tablets should match the color, shape, size and imprint. Please note: It is normal for speckling and brown coloration to vary from tablet to tablet.

     

  2. Refrain from administering any tablets that are questionable in color, shape, size or imprint. If all the tablets in the bottle match the description in the visual guide, you should continue to give your pet his/her medication as directed by your veterinarian.
  3. If you discover that any tablet differs from the visual guide, please contact your veterinarian immediately for advice.
  4. If you have additional questions related to the product or the halting of production, call Novartis Animal Health’s department of Technical Product Services at 1-800-637-0281 and press 5 to speak with a representative (available Monday-Friday 8 a.m. to 7 p.m. Eastern Time).

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