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Novartis Warns of Foreign Tablet Risk with Clomicalm

Posted: Jan. 26, 2012, 5:45 p.m. EST

Clomicalm
Novartis Animal Health cautioned dispensers of Clomicalm that the product could contain foreign tablets.

(Update: As of Feb. 3, 2012, Novartis resumed U.S. shipments of animal drugs already manufactured at the Lincoln, Neb., plant.)

Novartis Animal Health cautioned veterinarians yesterday that foreign tablets may be found in certain bottles of Clomicalm (clomipramine hydrochloride) tablets.

The company issued the warning via a “Dear Doctor” letter as a precautionary measure, 17 days after its consumer health division recalled several products packaged at a facility in Lincoln, Neb., over similar concerns. No instances of foreign tablets in Clomicalm bottles have been reported to Novartis. Clomicalm is one of five Novartis products currently experiencing a supply disruption after the company voluntarily suspended operations at the Lincoln facility.

Novartis recommended clinic staff open each bottle of Clomicalm and examine its contents for tablets that are broken or are incorrect in color, shape or size. If any abnormalities are found, Novartis recommended returning the product and reporting the findings to the company by calling 800-637-0281.

Novartis also issued a “Dear Valued Customer” letter for clinics to distribute to affected pet owners, and recommended that clinics inform clients who have already received Clomicalm examine the tablets and refrain from administering any that are questionable in color, shape or size.

Novartis has resumed animal health product shipments from the Lincoln facility to Canada and overseas, but several products, including Clomicalm, Interceptor (milbemycin oxime) flavor tabs, Sentinel (milbermycin oxime-lufenuron) flavor tabs, Program (lufenuron) flavor tabs and suspension and Deramaxx (dercoxib), are not shipping domestically from the Lincoln facility. The company cannot say when domestic shipments will resume, but it is working to achieve the same end result for the U.S. it achieved for Canada and abroad, said Joseph Burkett, global head of communications for Novartis Animal Health.

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