Veterinary drugs produced by Novartis at its Lincoln, Nebraska plant are temporarily unavailable following two FDA inspections that resulted in extensive 483s and the firm’s decision to halt production while the issues were being addressed.
Some alternatives to the drugs impacted at the Lincoln facility, manufactured by Novartis’ generics division Sandoz at its Boucherville, Quebec, Canada site, are also in short supply stemming from a mid-November FDA warning letter at the site (IPQ “The News in Depth” Jan. 3, 2012). In its wake, Sandoz discontinued several medications and downsized production of others at the site.
A fire that broke out in early March in the plant’s boiler room exacerbated the manufacturing challenges.
In late March, Novartis sent a letter to veterinary product customers explaining that the production shutdown at Lincoln “has created a backorder situation” resulting in “significant challenges for practices and pet owners who rely on Novartis Animal Health products.”
Consumer complaints of bottles containing mixed-up or damaged tablets and capsules for human medications and the two FDA inspections also prompted Novartis to recall a handful of its over-the-counter (OTC) products and temporarily cease operations at Lincoln in early January “to accelerate maintenance and other improvement activities at the site” (IPQ “The News in Depth” Jan. 14, 2012).
The consumer-level recall involved lots of Excedrin, Bufferin, NoDoz and Gas-X Prevention tabs and caps. Also in January, Novartis warned veterinarians of possible tablet mix-ups in bottles of the anti-anxiety medication Clomicalm (clomipramine hydrochloride), manufactured at the Lincoln site. The company characterized the discovery of the wrong tablets in Clomicalm bottles as a “rare possibility.”
The March letter to veterinarians explained that “given the large number of lines and products manufactured in Lincoln…the exact timelines remain uncertain. We hope to be able to give you a definitive date for a restart within the next few weeks.”
Veterinarians have been dealing with Novartis backorders since mid-December, when the company ceased production of animal health products made at the Lincoln plant.
Veterinary-specific drugs manufactured at the Lincoln facility include Interceptor Flavor Tabs, Sentinel Flavor Tabs, Clomicalm (clomipramine hydrochloride), and Milbemite.
According to the online trade journal Veterinary Information Network, some veterinarians are switching their patients to alternative medications – some of them labeled for human use but commonly used for animals.
A Canadian Veterinary Medical Association (CVMA) alert notes that the supplies of eight human-labeled medications from Sandoz that veterinarians frequently use are being impacted: midazolam, glycopyrrolate, fentanyl, hydromorphone, meperidine, morphine, diazepam and phenobarbital.[/membership]