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Fort Dodge Animal Health |
Michael LaRoch, DVM |
Dear Doctor:
As you may be aware, media in several markets are running stories about a voluntary recall of ProHeart ®6. This media coverage may result in questions from clients and staff, and we feel it is important to provide you with the facts about the voluntary recall and what it means for you and your clients. We trust this information will be useful, and encourage you to call our Professional Services department at 1-800-533-8536 if you have additional questions.
This past April, Fort Dodge Animal Health initiated a voluntary recall of ProHeart 6 (moxidectin) 5-pack lots 367158214 and 367158215 to the distributor/retail (veterinary) level. These lots were recalled due to dissolution results that were marginally out of specification for a few vials during routine six-month testing. Dissolution tests are part of a panel of tests conducted before the release of any product, and repeated at set time intervals throughout the shelf life of the product.
It is important to note these two lots of ProHeart 6 met all dissolution specifications at all time points during the routine testing, some vials showed a slightly slower dissolution rate at the 2 and 2.5 hour time points, but were within the specified levels at 1, 1.5 and 4 hours. These lots of ProHeart 6 also met all other specifications and passed all quality control tests established and approved by the FDA. No other lots were included in this voluntary recall.
Overall, Fort Dodge Animal Health has manufactured more than 1.9 million vials of ProHeart 6. ProHeart 6 has helped to prevent canine heartworm disease in millions of healthy dogs throughout the country. It continues to e a safe and effective product for the vast majority of patients that receive it. We trust this reflects your ongoing experience, as well. To further assist you in responding to clients and staff, we have developed some brief questions and answers for your reference.
Finally, because of this recent media coverage, we feel relatively certain the media will also try to incorporate information about an unrelated voluntary recall initiated last month. We want to ensure you are aware of this situation and have the facts about this matter. Fort Dodge received a warning letter from the FDA regarding issues in the sterile filling area of its Fort Dodge, Iowa, manufacturing facility. The company initiated a voluntary recall to the distributor/retail (veterinary) level for several lots of sterile veterinary pharmaceutical products filled between August 29, 2003 and January 12, 2004, one of which was the vehicle for ProHeart 6, which is provided in the same box as the microspheres.
This action was a precautionary measure to address issues cited in the FDA warning letter. All products included in the voluntary recall mete all specifications and passed all quality control tests established and approved by the FDA. Fort Dodge maintains an outstanding track record of manufacturing safe and efficacious products. The company continues to be committed to enhancing our existing quality systems to support sustained compliance with current Good Manufacturing Practices (cGMP), and to ensure our continued leadership as a provider of innovative pharmaceuticals to the animal health industry.
Again, please contact our Professional Services Department at 1-800-533-8536 if you have additional questions. Thank you for your attention to this important information.
Regards,
<signed>
Michael LaRosh, DVM
Director, Companion Animal
Professional and Technical Services
Enclosure
Proheart 6 is generally well tolerated. Use with caution in sick, debilitated or underweight animals. A small percentage of dogs showed mild, transient swelling or itching at the injections iste. While rare, digestive, neurological or hypersensitivity reactions may occur. For prescribing information see the package insert of call 1-800-477-1365
Enclosures:
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Fort Dodge Animal Health |
Kelly Goss |
What was the reason for the voluntary recall?
This past April, Fort Dodge Animal Health initiated a voluntary recall of ProHeart 6 (moxidectin) 5-pack lots 367158214 and 367158215 to the distributor/retail (veterinary) level. These lots were recalled due to dissolution results that were marginally out of specification for a few vials during routine six-month testing. Dissolution tests are part of a panel of tests conducted before the release of any product, and repeated at set time intervals throughout the shelf life of the product.
It is important to note these two lots of ProHeart 6 met all dissolution specifications at all time points during the routine testing that occurred prior to the distribution of the product. During routine six-month testing, some vials showed a slightly slower dissolution rate at the 2 and 2.5 hour time points, but were within the specified levels at 1, 1.5 and 4 hours. These lots of ProHeart 6 also met all other specifications and passed all quality control tests established and approved by the FDA. No other lots were included in this voluntary recall.
What product is affected by this voluntary recall?
Only ProHeart 6 ) 5-pack lots 367158214 and 367158215 are included in this voluntary recall. No other lots of ProHeart 6 are affected by the recall.
Do I need to contact my clients about the voluntary recall?
No, the voluntary recall did not extend to pet owners.
Were other product lots tested? What were the results?
All lots manufactured are tested prior to release to the market. As required by FDA, dissolution tests were conducted on the lots manufactured before and after these lots as part of our analysis. All met criteria for dissolution.
Why are dissolution tests performed?
Dissolution testing is a routine Quality Control Test required by the FDA for solid dosage forms such as tablets, implants and microspheres. The test monitors release of the drug from the solid dosage form as it dissolves. The primary purpose is to measure and ensure consistent drug release characteristics between batches. The test method is specific for the product and is approved by the FDA.
Is there any connection between recent media coverage of ProHeart 6 and this voluntary recall?
No, however, the media is attempting to link this voluntary recall to adverse events. As you may remember, many of the media stories focused on pet owners who felt their dogs had experience adverse reactions to the product. While Fort Dodge submitted complete and accurate information about the cases involved in the stories, as well as the facts about the safety and efficacy of ProHeart 6, the news organizations focused instead on sensationalizing the issue. Some chose to ignore the documented facts, as well as academicians and practicing veterinarians who were contacted for the stories.
Extensive safety studies have demonstrated ProHeart 6 is safe for all types of healthy dogs six months of age and older. In field clinical studies, ProHeart 6 was also proven safe when used in conjunction with other medications commonly administered at veterinary hospitals.
Since its launch in June 2001, millions of doses of ProHeart 6 have been safely and effectively administered to a wide variety of healthy dogs.
