Clomicalm mixup warning from Novartis

Novartis is warning customers that broken or incorrect tablets may be found in bottles of Clomicalm as a result of packaging issues at a Novartis manufacturing facility in Lincoln, Neb.

Clomicalm is a drug designed to alleviate canine separation anxiety.

Though Novartis says it has not received any reports where a patient discovered a product mix-up, it sent a letter to doctors Jan. 25, 2012 recommending that proper precautions be taken to avoid dispensing mis-packaged drugs.

Novartis is encouraging doctors to open each bottle of Clomicalm and look for tablets that are broken or incorrect in color, shape or size before dispensing any medications.

"Inform your clients who have already received Clomicalm to examine tablets and refrain from administering any that are questionable in color, shape or size; and to contact Novartis Animal Health to discuss product return of affected bottles," Novartis wrote to doctors.

Novartis also gave veterinarians a Dear Valued customer letter to distribute throughout clinics and to affected pet owners, recommending that clinics include the notice in any newsletters they send out.

"Keep records of communication with pet owners in patient files," Novartis advised doctors.

The drug maker requested that doctors complete and return a Response Card to show that they had read and understood the recommendations from Novartis, and that doctors had discussed them with their clients.

The warning from Novartis comes after the manufacturer voluntarily shut down its Lincoln facility in December. The shutdown affected key products such as heartworm medications Interceptor and Sentinel, as well as Clomicalm, Deramaxx, Program and Milbemite as well as other human over-the-counter (OTC) medications.

The Novartis Consumer Health division announced Jan. 8, 2012 that is was voluntarily recalling all lots of select bottles of Excedrin and NoDoz products as well as select lots of Bufferin and Gas-X Prevention. Citing consumer complaints of chipped and broken pills and inconsistent bottle packaging, Novartis said the OTC products may contain stray tablets, capsules or caplets from other Novartis drugs also packaged at the same facility.

Novartis had previously announced that it would increase prices for the drugs Clomicalm, Interceptor, Sentinel, Deramaxx, Program and Milbemite on Feb. 1, 2012. Because of the facility shutdown, Novartis announced it would not raise prices on the affected drugs, and that it would temporarily waive shipping fees that typically apply to orders under $200.

Customers who notice broken or incorrect tablets should report their findings to Novartis Animal Health at 800-637-0281. Customers should also return affected products to Novartis.

Novartis has given no indication as to when production at the Lincoln, Neb. facility will resume.
Affected lots of Clomicalm: