News
Virbac Announces Voluntary Recall Notice for Selected Production Lots of IVERHART PLUS® Flavored Chewable Tablets
On Thursday, August 13, 2009 Virbac AH, Inc., the manufacturer of IVERHART PLUS® Flavored Chewable Tablets, a heartworm preventive medicine, announced a voluntarily recall of three product lots.
It is important to note that prior to releasing the identified product lots for sale and distribution, numerous tests (including ivermectin) were performed and the ivermectin test results were within specifications permitting the release of the product. After release, Virbac performed routine stability testing at FDA-approved time intervals. This stability testing revealed subpotent (below specification) ivermectin results in two lots, IVERHART PLUS, large 51-100 lbs. (lots #090093 and #090095) and one lot, IVERHART PLUS, small up to 25 lbs. (lot #090073) nearing the lower potency limit. No other lots have been affected by this recall.
Virbac, after notifying the FDA, is coordinating with our distributor network to voluntarily recall the product. Letters have been sent directly to veterinary distributors instructing them to cease distribution of the identified lots and to advise veterinary clinics in receipt of the identified products to cease dispensing the affected lots.
Virbac regrets this isolated incident and remains committed to manufacturing quality products. No adverse reactions or illnesses have been reported with these products.
It is Virbac’s goal to ensure that all dogs receive adequate protection against heartworm disease. Veterinary clinics are urged to contact pet owners to check any IVERHART PLUS Flavored Chewable Tablets in their homes to see if it contains one of the identified lot numbers. If so, the pet owner should return it to their place of purchase as soon as possible for replacement IVERHART PLUS Flavored Chewable Tablets from a different lot number. The lot number is listed on the bottom lid/flap of the box in a white text field and on the blister foil of the individual doses. Virbac will provide full replacement through the distributor network.
Virbac cautions that dogs weighing over 75 pounds, which may have been dosed with the identified lots, may not be currently protected against heartworm disease. Virbac recommends that these dogs receive a heartworm test 5 to 6 months after the date of the last dose given, in order to verify continued protection against heartworm disease. If any dog receiving IVERHART PLUS Flavored Chewable Tablets was infected with heartworms, treatment can be administered and will be covered under the IVERHART PLUS product guarantee. Virbac Technical Services (800-338-3659 extension 3052 or fax-817-831-9906) is committed to working with clients and veterinary clinics to accomplish any necessary antigen testing of dogs at risk that received the identified lots.
Virbac is confident that dogs weighing less than 75 pounds are currently protected against heartworm, but the identified product may not work at acceptable levels through the expiration date. Therefore it is important that pet owners and veterinary clinics replace the recalled lots as soon as possible. Since only the ivermectin is affected, there is no additional risk related to the internal parasites covered by the product.
Testing has confirmed that all other lots of IVERHART PLUS Flavored Chewable Tablets remain potent. Only the three lots identified are affected by this recall.