Novartis issues alert to veterinarians regarding Clomicalm

Manufacturing problem cited as a 'rare possibility'
source-image
Feb 01, 2012
By dvm360.com staff
East Hanover, N.J. -- Novartis Animal Health is warning veterinarians of a "rare possibility" that a wrong tablet might be found in some 30-count bottles of Clomicalm® (clomipramine hydrochloride) tablets.

The company sent a letter to veterinarians Jan. 25, explaining the possible mix-up is the result of potential packaging issues at its manufacturing facility. No reports of adverse events have been reported in the drug, which is used to treat canine separation anxiety.

In the letter, Novartis did not recommend a full recall, but advised veterinarians to take certain precautionary measures, including alerting veterinary clients and checking the tablets for broken or incorrect sized or shaped pieces in each bottle of Clomicalm prior to dispensing.

Novartis urges veterinarians to report abnormal findings to the company at (800) 637-0281 and to return affected products to the company.

Products potentially impacted by this warning were distributed in 30-count bottles and include the following:

• Clomicalm 5 mg
— lot number 10098776, expiration date 9/13

• Clomicalm 20 mg
— lot number 10122354, expiration date 8/14
— lot number 10098779, expiration date 10/13
— lot number 10085841, expiration date 6/13
— lot number 10079205, expiration date 10/12
— lot number 10072783, expiration date 7/12
— lot number 10063973, expiration date 2/12

• Clomicalm 40 mg
— lot number 10120764, expiration date 8/14
— lot number 10098775, expiration date 10/13
— lot number 10092743, expiration date 6/13
— lot number 10082033, expiration date 1/13
— lot number 10072784, expiration date 7/12
— lot number 10061894, expiration date 2/12

• Clomicalm 80 mg
— lot number 10125584, expiration date 10/14
— lot number 10115214, expiration date 6/14
— lot number 10098781, expiration date 10/13
— lot number 10092746, expiration date 7/13
— lot number 10082034, expiration date 1/13
— lot number 10072785, expiration date 9/12 >
— lot number 10065183, expiration date 2/12