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U.S. Department of Health and Human Services

Enforcement Report - Week of November 13, 2013

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Product Detail

Product Description Virbac Iverhart Plus (ivermectin/pyrantel) Flavored Chewables, 272 mcg Ivermectin and 227 mg pyrantel as pamoate salt, 6 chewables/blister pack, Recommended for dogs 51 to 100 lbs. ANADA 200-302. Manufactured by Virbac A, Inc, Fort Worth, TX. VETIQ HeartShield Plus (ivermectin/pyrantel) Flavored Chewables, 272 mcg Ivermectin and 227 mg pyrantel as pamoate salt, 6 chewables/blister pack, Recommended for dogs 51 to 100 lbs. ANADA 200-302. NDC 49994-305-06. Manufactured for: TruRX, LLC, Eagle, ID. Worm Shield (ivermectin/pyrantel) Flavored Chewables, 272 mcg Ivermectin and 227 mg pyrantel as pamoate salt, 6 chewables/blister pack, Recommended for dogs 51-100 lbs. ANADA 200-302. Manufactured for: Schuyler LLC, Portland, OR.
Recall Number V-003-2014
Classification Class III
Code Info Lot numbers and expiration dates of recalled product failing ivermectin potency: Iverhart Plus- 111394, exp 12/2013; 120091, exp 01/2014; 120377, exp 03/2014; 120440, exp 04/2014120651, exp 04/2014; 120658, exp 05/2014; 120824, exp 06/2014 and 120831, exp 06/2014. Wormshield- 120093, exp 01/2014 and 120824, exp 06/2014. Heartshield- 120831, exp 06/2014. Lot numbers and expiration dates of recalled product with passing potentcy but expected to fail: Iverhart Plus- 120127, exp 02/2014; 120207, exp 02/2014; 120256, exp 01/2014; 120289, exp 02/2014; 120300, exp 02/2014; 120306, exp 02/2014; 120434, exp 03/2014; 120464, exp 04/2014; 120678, exp 05/2014; 121110, exp 07/2014; 121150, exp 09/2014; 121283, exp 10/20; and 14121386, exp 10/2014. Wormshield- 120464, exp 04/2014; 120649, exp 04/2014 and 120678, exp 05/2014. Heartshield- 120811, exp 05/2014.
Product Distributed Qty 87,359/10/6 tablet-blister pack/display boxes
Reason For Recall The products were identified during an ongoing investigation and testing as being out-of-specification for Ivermectin potency.

Event Detail

Event Id 66017
Product Type Veterinary
Status Ongoing
Recalling Firm Virbac Corporation
City Bridgeton
State MO
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-09
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Distribution was made to CA, FL, HI, IA, IN, KS, MD, MI, MN, MO, MS, NE, NJ, NM, OK, OR, PA, TN, TX, WI, Firm also distributed to PR.
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