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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
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
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 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
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 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
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
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
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