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Virbac Announces Voluntary Recall Notice for One Lot of IVERHART MAX® Chewable Tablets (ivermectin / pyrantel pamoate / praziquantel)
March 26, 2012
On Monday, March 26, 2012 Virbac AH, Inc. announced a voluntary recall of a single production lot of IVERHART MAX® Chewable Tablets.
Affected Product: IVERHART MAX Chewable Tablets, Lot #110482 (Large, 50.1 - 100 lbs)
The lot number is stamped on the side lid/flap of the box in a white text field and on the blister foil of the individual doses. Please note that this voluntary recall affects only this specific lot – no other products are affected by this recall.
Virbac, after promptly notifying the FDA, is coordinating with our distributor network to voluntarily recall the affected product. Letters have been sent directly to veterinary distributors instructing them to cease distribution of this identified lot and to advise veterinary clinics in receipt of the identified product to cease dispensing this affected lot.
It is important to note that prior to releasing the identified product lot for sale and distribution, numerous tests were performed and all test results were within specifications permitting the release of the product. After release, routine product testing has determined that the ivermectin (an active ingredient) has failed to meet our required stability specifications. Consequently, some dogs dosed with the identified lot may not be fully protected against heartworm disease.
It is Virbac’s goal to ensure that all dogs receive adequate protection against heartworm disease. For potentially affected dogs, veterinarians should contact Virbac Technical Services (800-338-3659 x3052) to discuss recommendations for heartworm testing procedures. If any dog receiving IVERHART MAX Tablets is found infected with heartworms, treatment can be administered and will be covered under the IVERHART product satisfaction guarantee.
Virbac regrets this isolated incident and remains committed to manufacturing quality products. Testing has confirmed that all other lots of IVERHART MAX Chewable Tablets remain potent. Only this single lot is affected by this recall. Since only the ivermectin is affected, protection against other internal parasites covered by the product is not compromised. Additionally, no heartworm-related adverse events or illnesses have been reported to-date with this lot of product.
One of the world’s largest laboratories dedicated exclusively to animal health - Virbac develops, manufactures and distributes a wide range of products and services intended for the prevention and treatment of common pathologies in companion animals. Virbac Corporation U.S., located in Fort Worth, Texas, is a leading companion animal health company offering products in the heartworm, tick and flea, dermatology, antibiotic, endocrinology, senior care, behavior, critical care nutrition, and oral hygiene markets. Virbac products are available to pet owners through their veterinarian. For more information about Virbac Animal Health and the company’s products, please visit www.virbacvet.com.
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Michael Walsh, Market Development
Virbac Animal Health