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)
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.
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.
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
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