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U.S. Department of Health and Human Services

Enforcement Report - Week of August 28, 2013

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Event Detail

Event ID 65663
Product Type Drugs
Status Ongoing
Recalling Firm Stayma Consulting Service, LLC.
City Suwanee
State GA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-28
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Nationwide.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Nata Komplete, containing one 30-count bottle of multi-vitamin tablets (imprinted 909), Manufactured for W.H. Nutritionals, Wilmington, DE (NDC 76331-909-30) and physician samples of nine bottles of 5-multi-vitamin tablets (NDC 76331-909-05 ) NDC 76331-909-30; Lot 40186, exp 5/14 NDC 76331-909-05; Lot 40186, exp. 5/14 (physician samples) Class III Subpotent; Beta carotene (Vitamin A) 1974 and 3967 physician samples D-900-2013
Duet DHA 430 ec, containing one 30-count bottle of multi-vitamin tablets (imprinted 800) and one 30-count bottle of Omega-3 softgel capsules, Manufactured for W.H. Nutritionals, Wilmington, DE (NDC 76331-810-30) NDC 76331-810-30; Lot 39736A, exp. 3/14 Class III Subpotent; Beta carotene (Vitamin A) 1492 D-899-2013
Duet DHA 430, containing one 30-count bottle of multi-vitamin tablets (imprinted 800) and one 30-count bottle of Omega-3 softgel capsules, Manufactured for W.H. Nutritionals, Wilmington, DE --- NDC 76331-808-30 NDC 76331-808-30; lot 39736A, exp. 3/14 and lot 41667, exp. 12/14 Class III Subpotent; Beta carotene (Vitamin A) 2985 D-898-2013
NataChew, 1) one 90-count bottle of multi-vitamin tablets (imprinted 902), (NDC 44118-902-90) and 2) physician samples containing nine bottles with 5 multi-vitamin tablets (imprinted 902) (NDC 44118-902-05), Manufactured for Eckson Labs, Wilmington, DE 1) Lot 41065, exp 10/14 and 41099, exp 9/14 NDC 44118-902-90 2) Lot 41065A, exp. 9/14 NDC 44118-902-05 Class III Subpotent; Beta carotene (Vitamin A) 1) 4546 bottles and 2) 1349 bottles D-897-2013
Duet DHA 400 ec, containing one 30-count bottle of multi-vitamin tablets (imprinted 800) and one 30-count bottle of Omega-3 softgel capsules, Rx only, Manufactured for Eckson Labs, Wilmington, DE (NDC 44118-809-30) and Manufactured for W.H. Nutritionals, Wilmington, DE (NDC 76331-809-30) NDC 44118-809-30; Lot 40614B, exp. 9/14 and NDC 76331-809-30; lot 39736A, exp. 3/2014, Class III Subpotent; Beta carotene (Vitamin A) NDC 44118-809-30; 747 and NDC 76331-807-30; 1493 D-896-2013
Duet DHA 400, containing one 30-count bottle of multi-vitamin tablets (imprinted 800) and one 30-count bottle of Omega-3 softgel capsules, Rx only, Manufactured for Eckson Labs, Wilmington, DE (NDC 44118-807-30) --- Also Manufactured for W.H. Nutritionals, Wilmington, DE (NDC 76331-807-30) NDC 44118-807-30 Lots 40614, exp. 9/14 and 40614A, exp. 9/14 NDC 76331-807-30 lot 39736A, exp. 3/2014, and lot 41667, exp. 12/2014 Class III Subpotent; Beta carotene (Vitamin A) 1,460 and 2,990 D-895-2013
Duet DHA Balanced, 1) 30 count tablet blister cards and 5 count softgels blister cards combination pack (NDC 44118-775-30 and NDC 44118-800-30) 2) physician samples (carton contain 7 envelopes each with one 5 count tablet blister card and 5 softgels (NDC 44118-800-05) Rx only, Manufactured for Eckson Labs, Wilmington, DE 1) NDC 44118-775-30, Lots 12120001, exp. 10/14 and 12120002, exp. 10/14; NDC 44118-800-30, Lots 12120001, exp 10/14 and 12080002, exp 8/14 2) Physician Samples: NDC 44118-800-05, Lot 12080001 exp. 8/14 and 12120002, exp. 10/14 Class III Subpotent; Beta carotene (Vitamin A) 1) 12,278 and 28476; 2) 23740 D-894-2013
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