Earlier this month, Novartis recalled an unspecified number of over-the-counter drugs - including Excedrin, No-Doz and Bufferin - due to complaints about incorrect or chipped tablets and broken gelcaps. This came on the heels of an FDA inspection last summer that found a host of manufacturing problems, as well as repeated failures to follow up on consumer complaints or file reports with the agency (seethis and this).
As a result, the Lincoln, Nebraska, plant has been closed, although Novartis maintains it should reopen by the end of the year. That may be optimistic. The FDA has just completed another inspection and a new report dated January 20 found the same problems. These included a failure to do the following: train employees in quality systems, extend investigations of known problems to all products affected; assure processes remain in a current validated state and have an adequate number of trained staff in the quality unit (here is the most recent 483 report).
Meanwhile, the drugmaker is on track to lose hundreds of millions of dollars in lost sales, since the plant also made some Animal Health meds and conducted contract manufacturing for clients such as Endo Pharmaceuticals (read here). The troubles have been widely reported, by the way, and Novartis has issued at least one press release about the problems with over-the-counter meds (see this).
However, more than two weeks after Novartis alerted the public to the embarrassing problems, the drugmaker has finally gotten around to informing veterinarians that similar issues exist with one of the Animal Health meds that were made at the plant. The drug in question is Clomicalm, which is used to treat separation anxiety in dogs. A letter was sent on January 25 to vets to say that "there is a rare possibility that a wrong tablet may be found in bottles of Clomicalm with the enclosed lot numbers" (here is the letter, or you can read the text after the jump) .
This offers an ironic twist on concerns over separation anxiety: not only will dogs become more anxious with the wrong med, but now their owners - and even some vets - may become anxious as well. We asked Novartis why vets were not alerted earlier to the possibility that dogs could be exposed to the same sort of hazard as humans, given that the drugmaker was aware of the problems for months, suspended production weeks ago and notified its two-legged customers three weeks before vets were told about potential product mix-ups. No explanation was offered.
So far, Novartis emphasizes that it has not received any reports of adverse events or product mix-ups, but urges vets and pet owners to open and examine each bottle for tablets that are broken or incorrect in color, shape or size, according to the letter.
A Novartis spokesman wrote us to say the letter was sent "due to a rare possibility that a tablet from a different medicine may be found in Clomicalm bottles that have been distributed to clinics or dispensed to their clients... While we have no reason to believe that there were any mix-ups related to Clomicalm on the packaging line, we are taking this step to stay on the side of total caution."
January 25, 2012
IMPORTANT PRODUCT INFORMATION
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. However, as a precautionary measure, we would like to extend the following recommendations.
1) Before dispensing CLOMICALM, open each bottle and examine the contents for tablets that are broken or incorrect in color, shape or size (visual guide included). 2) Post a copy of the Dear Valued Customer letter issued by Novartis Animal Health in your clinic (copy included). 3) Distribute copies of the Dear Valued Customer letter to affected pet owners. Novartis Animal Health will send your clinic extra copies upon request. If you publish a clinic newsletter, please consider using the provided notice. 4) Report any abnormal findings to Novartis Animal Health at 800-637-0281. 5) Return affected product to Novartis Animal Health; call the aforementioned number for full details. 6) 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. 7) Keep records of communication with pet owners in patient files. 8) Ensure that any re-packaged tablet bottles are labeled with the product lot number. Novartis Animal Health requests that you complete and return the enclosed Response Card reflecting that you have read and understand these points, and have discussed them with your clients. Canine separation anxiety is a complex disorder that has great bearing on patient quality of life and the human-companion animal bond. Uninterrupted treatment is essential for successful management of this condition. Our veterinarians are prepared to discuss best practices with you in the event patients require alternative therapies, in order to minimize the risk of adverse events and potential relapse of signs.
We thank you for your attention and cooperation regarding this important issue. If you have any further questions, please contact Technical Product Services and Pharmacovigilance at 1-800-637-0281.
Sincerely, Doug Reece, DVM Medical Director Cynthia McCants Head of Quality Operations NAHUS, Inc.
Enclosures: Dear Valued Customer Letter Clomicalm Lots Clomicalm Tablets Size NAH Response Card Notice for Clinic Newsletter
January 25, 2012
Clomicalm® (clomipramine hydrochloride) 5mg (NDC number: 058198-4030-2) NAH Lot # Expiration Date Bottle Size 10098776 September 2013 30 Count
Clomicalm® (clomipramine hydrochloride) 20 mg (NDC number: 058198-4031-2) NAH Lot # Expiration Date Bottle Size
10122354 August 2014 30 Count 10098779 October 2013 30 Count 10085841 June 2013 30 Count 10079205 October 2012 30 Count 10072783 July 2012 30 Count 10063973 February 2012 30 Count
Clomicalm® (clomipramine hydrochloride) 40 mg (NDC number: 058198-4032-2) NAH Lot # Expiration Date Bottle Size
10120764 August 2014 30 Count 10098775 October 2013 30 Count 10092743 August 2013 30 Count 10082033 January 2013 30 Count 10072784 July 2012 30 Count 10061894 February 2012 30 Count Clomicalm® (clomipramine hydrochloride) 80 mg (NDC number: 058198-4033-2) NAH Lot # Expiration Date Bottle Size 10125584 October 2014 30 Count 10115214 June 2014 30 Count 10098781 October 2013 30 Count 10092746 July 2013 30 Count 10082034 January 2013 30 Count 10072785 September 2012 30 Count 10065183 February 2012 30 Count
dog pic thx to carabou on flickr