Serious FDA Inspectional Observations Dated January 30, 2012 to Novartis facility in Lincoln, Nebraska will affect numerous pet drugs. The following are excerpts from Phyllis Entis’s blog efoodalert.net.
“The recent shut-down of Novartis Consumer Health’s production facility in Lincoln, Nebraska has affected more than just Excedrin, Bufferin, NoDoz and Gas-X products. Veterinarians and pet owners also have been feeling the impact of Novartis’s abrogation of its quality assurance and product safety responsibilities.
Since issuing its product recall notice on January 8, 2012, the company has twice sent Dear Doctor letters to the veterinary community.”
Quoting from the second letter from Novartis to veterinarians…
Novartis Animal Health US, Inc. is committed to delivering safe and efficacious veterinary products, and would like to inform you about a recent development involving CLOMICALM® (clomipramine hydrochloride) tablets.
Due to potential packaging issues at our manufacturing facility, there is a rare possibility that a wrong tablet may be found in bottles of CLOMICALM with the enclosed lot numbers. Novartis has not received any reports where a patient experienced a product mix-up, nor has Novartis received any adverse events attributable to a product mix-up.”
If your pet takes a drug made by Novartis, please consult your veterinarian. For a list of pet products made by Novartis, click here.
To read Phyllis Entis’s full post on the Novartis FDA inspection, click here.
To read Phyllis Entis’s post on the Novartis pet drug concern, click here.