Excedrin & Interceptor – Back By Mid-Year?

Novartis has restarted manufacturing some products at its Lincoln, Nebraska facility. But the popular Excedrin OTC meds, and veterinary products such as Interceptor, are not yet in production.

According to a recent article in the Lincoln Journal Star, production of Opana tablets and morphine sulfate extended released has resumed. Novartis manufactures these, and other, prescription medicines under contract for Endo Pharmaceuticals.

As devotees of Excedrin and Interceptor (a veterinary medication used to prevent heartworm in dogs and cats) know, waiting for these products to return to market has been an exercise in patience.

And trying to find out when Novartis might resume production of these meds is an exercise in frustration.

On January 8, 2012 Novartis Consumer Health, Inc. recalled all lots of Excedrin, NoDoz, and other OTC products manufactured at its Lincoln, Nebraska production facility, and announced that it was suspending operations at the facility in order to “accelerate maintenance and other improvements” at the Lincoln operation. The shutdown affected the availability of a number of other human and animal meds that were produced in Lincoln, including the popular Interceptor heartworm preventative.

The recall and plant shutdown coincided with a scathing inspection report released by FDA in January. The report detailed numerous significant quality control problems at the Lincoln plant – many of them repeat observations first noted during earlier inspections.

Novartis has been close-mouthed about its timeframe for restarting production in Lincoln. According to a Novartis news release, the company told shareholders during its February 23rd Annual General Meeting that it was assuming a “…mid-year start of shipments out of the Lincoln plant.” But, two sentences later, the news release alluded to the possibility of a delayed start-up of Lincoln.

The only other clue to the start-up timeline comes from a March 16th letter to veterinarians, reported by the VIN News Service. In that letter, Novartis is reported to have acknowledged “a backorder situation” resulting from the Lincoln shutdown, affecting the popular veterinary products Interceptor Flavor Tabs and Sentinal Flavor Tabs. According to the VIN report, veterinarians were told that exact timelines for product availability remained uncertain. “We hope,” the Novartis letter is quoted as saying, “to be able to give you a definitive date for a restart within the next few weeks.”

On March 22nd, I sent a request for information by email to the Novartis recall email address, asking for any available information regarding the status of the Lincoln facility. On April 10th, I received a reply from Novartis Consumer Health spokesperson, Millicent Brooks. “In response to your inquiry,” she wrote, “we are working hard to resume production at our Lincoln facility and return OTC and Animal Health products, including Excedrin and Interceptor, to consumers as soon as possible.”

Some Excedrin users have reported purchasing the product on eBay. I would strongly advise against this option. There is no way of knowing whether the product being offered is authentic, or whether it has been stored under proper conditions.

Novartis will be releasing its next quarterly report to shareholders on April 24th. Let’s hope that the report will include an update on the Lincoln status, and that the news will be good.

Novartis Fiasco Affects Pet Meds, Too

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. The first letter, dated January 10th, warns veterinarians that the temporary suspension of production at the company’s Lincoln, Nebraska plant would affect the availability of certain Novartis Animal Health products. The letter begins:

Dear Valued Customer,

We are writing to inform you that Novartis Consumer Health, Inc. (NCH) has temporarily suspended production and product shipments at one of its manufacturing facilities, an action that will affect the availability of some Novartis Animal Health (NAH) products for the immediate future.

The manufacturing plant products both over-the-counter (OTC) and Animal Health products. NAH brands affected include Interceptor® Flavor Tabs®, Sentinel® Flavor Tabs®, Clomicalm®, Program® Tablets and Suspension, and Milbemite®. Production of Deramaxx, which was recently moved to the site, is also affected, although supplies on hand will continue to be shipped.

The second letter, which is dated January 25, 2012, is headed “IMPORTANT PRODUCT INFORMATION” and reads as follows:

Dear Doctor:

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.

If you are using any of these Novartis Animal Health brands, please keep in close touch with your veterinarian to stay current on supply and quality issues.

FDA Inspection Report Slams Novartis Inaction

“As of 12/12/11, your firm is overdue (untimely) with adequately conducting approximately 1,360 investigations you have received from consumer complaints (1332 are major, 31 are critical). This backlog of overdue complaints has been over 1,000 in number since at least 8/30/11.”

– FDA to Novartis Consumer Health (Lincoln, Nebraska), January 20, 2012

FDA has just released (January 30, 2012) a scathing 23-page Inspectional Observations (Form 483) report, which the agency issued to Novartis Consumer Health ten days ago, following completion of a reinspection of the company’s Lincoln, Nebraska facility.

The inspection report details numerous examples of egregious and unconscionable disregard for consumer safety on the part of Novartis Consumer Health – many of them issues that remain unaddressed since the facility was inspected last July. Consumer complaints of product mix-ups and chipped tablets have either not been investigated, or the investigation was inadequate, incomplete or delayed.

Some of the most flagrant deficiencies highlighted in the latest FDA report include:

As of 12/21/11, your firm … has approximately 360 consumer returned complaint samples of various products (major and critical complaints) that have not been thoroughly reviewed by your Quality Unit. … [The problems] requiring investigation include, but are not limited to: foreign product, foreign object, suspected tampering, chipped/cracked/crumbled tablets, broken/missing seal, etc. … Your firm is outside of procedural timeframes for completing approximately 340 open Corrective and Preventative Action requirements … and 48 deviation … investigations.

[I]nvestigation fails to address how “28 assorted tablets” (some not packaged in the room, such as Gas X, Soft Gels, etc) could have entered a room dedicated to packaging other products.

[I]nvestigation, opened 11/18/11 and closed 12/16/11, into a complaint for “12 extra tablets”, found by a pharmacist after opening a sealed bottle of Morphine Sulfate ER 30mg… is deficient. … This is important because this consumer complaint was recently closed and is indicative of how your firm is currently investigating consumer complaints.

Your most recent consumer complaint (opened 12/16/12 and closed 12/20/11) into Bufferin RS Tablets, Lot: 10095189, for partial/incomplete tablet caplets, dues not address all lots of product potentially affected by the problem of over-compressed tablets identified as the root cause. Your firm was aware of Partial/Incomplete Bufferin tablets/caplets issues since at least 2009, yet a Medical safety Assessment Report was not released until 10/14/11. There is no justification or explanation for the approximate 2 year delay in obtaining this report.

There is not root cause identified for the foreign tablets potentially in a Prevacid 15 MG Capsule container. … You have had 35 mixed tablet/foreign products for Prevacid 15 mg Capsules since 2009.

It is important to understand because of your firm’s failure to adequately and thoroughly conduct investigations, it is difficult to determine how widespread the problems are at your firm…

Your packaging line clearance operators failed to adequately clean packaging lines (and areas around packaging lines) during your “major” cleaning efforts of this equipment…

Your most recent Annual Product Review (APR) for Bufferin Extra Strength Tablets and Bufferin Regular Strength Tablets (2010) is incorrect. …

Your most recent 2011 Annual Product Review for Excedrin Extra Strength Express Gels … approved 5/27/11, is deficient. The report fails to document the consistent trend of complaints received by your firm for “Product Chipped, Cracked, Crumbled” and “Partial/Incomplete Tablet/Caplets” regarding this product. … Your firm has been aware of “Product Chipped, Cracked, Crumbled” and “Partial/Incomplete Tablet/Caplets” for this product (Express Gels) since at least 2009, yet a complete market correction (due to this problem) was not executed until 1/8/12, which occurred during the course of this FDA inspection.

The conclusion in your most recently completed 2011 Annual Product Review for Benefiber Plus Calcium Powder, signed as acceptable on 6/27/11, is not supported by the information in the report.

You have failed to document the root cause, and implement effective corrective and preventative actions, regarding product mix-up complaints for solid dosage form foreign tablets of products manufactured at your firm since at least 2009. (Referring to products such as: Excedrin family products, Prevacid, narcotic products, etc… Your foreign product recall assessment, dated 10/17/11, states you have received approximately 70 confirmed, returned customer complaint, mix-up samples containing only NCH-Lincoln produced product. In total, There have been 400 complaint cases of this type since 2009.

There is an inadequate number of Quality Unit personnel in your firm to conduct timely, correct and thorough reviews of the products you manufacture.

And, repeated over and over again throughout the 23-page report, is the statement – highlighted BY THE FDA INSPECTOR in upper case and bold-face:

THIS IS A REPEAT VIOLATION FROM THE PREVIOUS INSPECTION AT YOUR FIRM DATED 6/13-7/8/11

I would not be surprised to see another recall announcement from Novartis Consumer Health – one that covers all products manufactured by the company since 2009 at its Lincoln, Nebraska production plant.