🍔 Food 💊 Drugs 🏥 Medical Devices
Mavik¿ trandolapril tablets 4mg, 100 count bottle, Rx only, Manufactured by Halo Pharmaceutical Inc., Whippany, NJ for Abbott Laboratories, North Chicago, IL 60064, USA Class III

Reason: Labeling: Incorrect Package Insert; product packaged with outdated version of the insert

AbbVie Inc. 20130801 Terminated
Distributed: Nationwide
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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 ) Class III

Reason: Subpotent; Beta carotene (Vitamin A)

Stayma Consulting Service, LLC. 20130628 Terminated
Distributed: Nationwide.
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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) Class III

Reason: Subpotent; Beta carotene (Vitamin A)

Stayma Consulting Service, LLC. 20130628 Terminated
Distributed: Nationwide.
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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 Class III

Reason: Subpotent; Beta carotene (Vitamin A)

Stayma Consulting Service, LLC. 20130628 Terminated
Distributed: Nationwide.
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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 Class III

Reason: Subpotent; Beta carotene (Vitamin A)

Stayma Consulting Service, LLC. 20130628 Terminated
Distributed: Nationwide.
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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) Class III

Reason: Subpotent; Beta carotene (Vitamin A)

Stayma Consulting Service, LLC. 20130628 Terminated
Distributed: Nationwide.
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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) Class III

Reason: Subpotent; Beta carotene (Vitamin A)

Stayma Consulting Service, LLC. 20130628 Terminated
Distributed: Nationwide.
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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 Class III

Reason: Subpotent; Beta carotene (Vitamin A)

Stayma Consulting Service, LLC. 20130628 Terminated
Distributed: Nationwide.
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REEVA (triclosan) Antibacterial Hand Soap and Dishwashing Liquid, Green Apple, 0.10%, 24 fl oz. bottle, Distributed by Aldi Inc,. Batavia, IL 60510; UPC 0 4198 1525 8. Class II

Reason: Microbial Contamination of a Non-Sterile Products: Product was found to be contaminated with the bacteria, Sarcina Lutea.

Showline Automotive Products, Inc. dba US Soaps Mfg. Company 20130806 Terminated
Distributed: Nationwide
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buPROPion Hydrochloride Extended Release Tablets, USP 100 mg, 100 count carton, 10 blister cards of 10 individually blistered and labeled tablets, Rx only, Actavis South Atlantic LLC, Packaged and Distributed by: American Health Packaging, Columbus, OH --- NDC 68084-470-01 Class III

Reason: Failed Stability Specifications; out of specification results at the 9 month stability time point for color, dissolution and related compounds.

American Health Packaging 20130204 Terminated
Distributed: Nationwide
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