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U.S. Department of Health and Human Services

Enforcement Report - Week of November 13, 2013

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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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Virbac Iverhart Plus (ivermectin/pyrantel) Flavored Chewables, 68 mcg Ivermectin and 57 mg pyrantel as pamoate salt, 6 chewables/box, Recommended for dogs up to 25 lbs. ANADA 200-302. Manufactured by Virbac A, Inc, Fort Worth, TX. VETIQ Heart Shield plus (ivermectin/pyrantel), 68 mcg Ivermectin and 57 mg pyrantel as pamoate salt, 6 chewables/box, Recommended for dogs up to 25 lbs. Packaged 6 flavored chewables per blister pack. ANADA 200-302, NDC 49994-105-06. Manufactured for: TruRx, LLC, Eagle, ID. Worm Shield (ivermectin/pyrantel) Flavored Chewables, 68 mcg Ivermectin and 57 mg pyrantel as pamoate salt, 6 chewables/blister pack, Recommended for dogs up to 25 lbs. ANADA 200-302. Manufactured for: Schuyler LLC, Portland, OR. Lot numbers and expiration dates of recalled product failing ivermectin potency: Iverhart Plus- 120092, 10/2013; 120397, 12/2013 and 120398, 11/2013. Wormshield- 120397, 12.2013. Heartshield- NONE Lot numbers and expiration dates of recalled product with passing potentcy but expected to fail: Iverhart Plus- 120195, 02/2014 and 120798, 02/2014. Wormshield- 120195, 02/2014. Heartshield- 120798, 02/2014. Class III The products were identified during an ongoing investigation and testing as being out-of-specification for Ivermectin potency. 40,920/10/6 tablet-blister pack/display boxes V-004-2014
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. 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. Class III The products were identified during an ongoing investigation and testing as being out-of-specification for Ivermectin potency. 87,359/10/6 tablet-blister pack/display boxes V-003-2014
Virbac Iverhart Plus (ivermectin/pyrantel) Flavored Chewables, 136 mcg Ivermectin and 114 mg pyrantel as pamoate salt, 6 chewables/blister pack, Recommended for dogs 26 to 50 lbs. ANADA 200-302. Manufactured by Virbac A, Inc, Fort Worth, TX. VETIQ HeartShield Plus (ivermectin/pyrantel) Flavored Chewables, 136 mcg Ivermectin and 114 mg pyrantel as pamoate salt, 6 chewables/blister pack, Recommended for dogs 26 to 50 lbs. ANADA 200-302. NDC 49994-205-06. Manufactured for: TruRX, LLC, Eagle, ID. Worm Shield (ivermectin/pyrantel) Flavored Chewables, 136 mcg Ivermectin and 114 mg pyrantel as pamoate salt, 6 chewables/box, Recommended for dogs 26-50 lbs. ANADA 200-302. Manufactured for: Schuyler LLC, Portland, OR. Virbac Iverhart Plus Lot numbers and expiration dates of recalled product failing ivermectin potency: 120378, 03/2014; 120090, 01/2014; 120301, 02/2014; 120305, 02/2014; 120692, 05/2014 ****Lot numbers and expiration dates of recalled product with passing potentcy but expected to fail: 121282, 10/2014 and 120450, 02/2014. Worm Sheild Lot numbers and expiration dates of recalled product failing ivermectin potency: 120090, 01/2014; 120301, 02/2014; 120305,02/2014. ****Lot numbers and expiration dates of recalled product with passing potentcy but expected to fail: 120450, 04/2014 Heartshield Lot numbers and expiration dates of recalled product failing ivermectin potency: 120692, 05/2014. ****Lot numbers and expiration dates of recalled product with passing potentcy but expected to fail: NONE Class III The products were identified during an ongoing investigation and testing as being out-of-specification for Ivermectin potency. 32,870/10/6 tablet-blister pack/display boxes V-002-2014
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