Products distributed to Florida, Nevada and the Dominican Republic
Chinen Dietary Supplement (unknown container size)
Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.
The Decree was entered on September 25, 2015.    Known lot: Lot # 380615
The Decree was entered on September 25, 2015.    Known lots and expiration dates: Lot # 190714 Exp. Date 07/17, Lot # 021214 Exp. Date 12/17, Lot # 281214 Exp. Date 12/17, Lot # 010315 Exp. Date 03/18, Lot # 061114 Exp. Date 11/17
The Decree was entered on September 25, 2015.    Known lot and expiration date: Lot # 181014 Exp. Date 10/17
Jagra Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 470315
Temil Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 070315
Body Shape Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 130715
Liver Clean Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 120715, 450815
The Decree was entered on September 25, 2015.    Known lot and expiration date: Lot # 520414 Exp. Date 04/17
Blable Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 081214
The Decree was entered on September 25, 2015.    Known lot: Lot # 101214
The Decree was entered on September 25, 2015.    Known lots and expiration dates: Lot # 300614 Exp. Date 06/17, Lot # 480614 Exp. Date 10/17
Tevass 2 Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 490615
The Decree was entered on September 25, 2015.    Known lot and expiration date: Lot # 260814 Exp. Date 08/17
Esclewe Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 340115
The Decree was entered on September 25, 2015.    Known lots and expiration dates: Lot # 400514 Exp. Date 06/17, Lot # 180614 Exp. Date 06/17, Lot # 190614 Exp. Date 08/17, Lot # 650614 Exp. Date 07/17
Kudo Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 391214, 440315, 240615, 500615
Hecle Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 190215, 250515
Neurocetin Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 110315
The Decree was entered on September 25, 2015.    Known lots and expiration dates: Lot # 390514 Exp. Date 06/17, Lot # 350614 Exp. Date 06/17,  Lot # 630614 Exp. Date 06/17, Lot # 640614 Exp. Date 06/17,  Lot # 670614 Exp. Date 08/17, Lot # 421014 Exp. Date 11/17,  Lot # 431014 Exp. Date 12/17
Collagen Hydrolyced Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lots and expiration dates: Lot # 170614 Exp. Date 08/17, Lot # 200515 Exp. Date 06/18
The Decree was entered on September 25, 2015.    Known lot and expiration date: Lot # 040614 Exp. Date 07/17
The Decree was entered on September 25, 2015.    Known lots and expiration dates: Lot # 030614 Exp. Date 07/17, Lot # 460814 Exp. Date 09/17, Lot # 080914 Exp. Date 10/17, Lot # 090914 Exp. Date 10/17, Lot # 021114 Exp. Date 11/17, Lot # 050115 Exp. Date 02/18, Lot # 030415 Exp. Date 05/18
The Decree was entered on September 25, 2015.    Known lots and expiration dates: Lot # 020614 Exp. Date 08/17, Lot # 450714 Exp. Date 08/17, Lot # 410814 Exp. Date 09/17, Lot # 420814 Exp. Date 08/17, Lot # 510914 Exp. Date 10/17
LOISIM Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 111114
The Decree was entered on September 25, 2015.    Known lots and expiration dates: Lot # 470514 Exp. Date 06/17, Lot # 400814 Exp. Date 09/17, Lot # 100914 Exp. Date 09/17, Lot # 271114 Exp. Date 12/17, Lot # 370115 Exp. Date 02/18, Lot # 540614 Exp. Date 08/18
The Decree was entered on September 25, 2015.    Known lots and expiration dates: Lot # 020415 Exp. Date 05/18, Lot # 080515 Exp. Date 06/18
The Decree was entered on September 25, 2015.    Known lots and expiration dates: Lot # 470414 Exp. Date 06/17, Lot # 420714 Exp. Date 08/17, Lot # 020914 Exp. Date 10/17, Lot # 231214 Exp. Date 01/18, Lot # 220615 Exp. Date 07/18
Heci Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 500814, 071214, 040415, 330615
The Decree was entered on September 25, 2015.    Known lots and expiration dates: Lot # 010614 Exp. Date 06/17, Lot # 520914 Exp. Date 10/17, Lot # 530914 Exp. Date 10/17, Lot # 181114 Exp. Date 12/17
The Decree was entered on September 25, 2015.    Known lots and expiration dates: Lot # 190814 Exp. Date 08/17, Lot # 030115 Exp. Date 02/18, Lot # 190415 Exp. Date 06/18
The Decree was entered on September 25, 2015.    Known lot and expiration date: Lot # 380514 Exp. Date 05/17
Collagen & VIT C, 60 capsules per bottle
The Decree was entered on September 25, 2015.    Known lots and expiration dates: Lot # 160415 Exp. Date 04/18, Lot # 270415 Exp. Date 04/18, Lot # 280415 Exp. Date 06/18, Lot # 290415 Exp. Date 05/18, Lot # 550615 Exp. Date 06/18, Lot # 560615 Exp. Date 07/18, Lot # 530814 Exp. Date 09/17, Lot # 120115 Exp. Date 01/17, Lot # 360515 Exp. Date 06/18
The Decree was entered on September 25, 2015.    Known lots and expiration dates: Lot # 130414 Exp. Date 04/17, Lot # 261214 Exp. Date 12/17,  Lot # 040815 Exp. Date 08/18
Super Male Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 050515, 200815
Bioxtron Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot and expiration date: Lot # 300415 Exp. Date 07/18
The Decree was entered on September 25, 2015.    Known lot and expiration date: Lot # 130615, 240215 Exp. Date 03/18
The Decree was entered on September 25, 2015.    Known lot and expiration date: Lot # 250115 Exp. Date 01/18
The Decree was entered on September 25, 2015.    Known lot and exp date: Lot # 380414 Exp Date 04/17, Lot #310614 Exp Date 07/17, Lot # 391014 Exp Date 12/17
Shilaji Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 090215
Moringa, 750 mg, Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 500315
Chardon De Marie, 60 capsules per bottle
The Decree was entered on September 25, 2015.    Known lots and expiration dates: Lot # 290414 Exp. Date 04/17, Lot # 280414 Exp. Date 05/17,   Lot # 660514 Exp. Date 06/17, Lot # 030714 Exp. Date 07/17,   Lot # 670514 Exp. Date 07/17, Lot # 680514 Exp. Date 10/17,   Lot # 131214 Exp. Date 12/17, Lot # 151214 Exp. Date 02/18
First Defense Probiotic Dietary Supplement (unknown container size)
Amitad Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 160514
The Decree was entered on September 25, 2015.    Known lot and expiration date: Lot # 011014 Exp. Date 10/17
Test Booster, 90 or 60 capsules per bottle
The Decree was entered on September 25, 2015.    Known lots and expiration dates: Lot # 011114 Exp. Date 11/17, Lot # 010215 Exp. Date 02/18, Lot # 130215 Exp. Date 02/18, Lot # 191014 Exp. Date 10/17
The Decree was entered on September 25, 2015.    Known lot and expiration date: Lot # 340315 Exp. Date 03/18
The Decree was entered on September 25, 2015.    Known lots and expiration dates: Lot # 460514 Exp. Date 06/17, Lot # 160814 Exp. Date 08/17, Lot # 060215 Exp. Date 02/18, Lot # 070215 Exp. Date 02/18, Lot # 010515 Exp. Date 06/18, Lot # 270615 Exp. Date 08/18, Lot # 020815 Exp. Date 08/18
The Decree was entered on September 25, 2015.    Known lots and expiration dates: Lot # 051214 Exp. Date 12/17, Lot # 160515 Exp. Date 05/18, Lot # 260515 Exp Date 05/18
Naer Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 240515
The Decree was entered on September 25, 2015.    Known lots and expiration dates: Lot # 271014 Exp. Date 10/17, Lot # 281014 Exp. Date 12/17, Lot # 291014 Exp. Date 03/18, Lot # 301014 Exp. Date 04/18,  Lot # 311014 Exp. Date 05/18, Lot # 230615 Exp. Date 05/18,  Lot # 301114 Exp. Date 11/17
The Decree was entered on September 25, 2015.    Known lots and expiration dates: Lot # 220714 Exp. Date 07/17, Lot # 190115 Exp. Date 01/18, Lot # 320615 Exp. Date 06/18
Insulow Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 480815
The Decree was entered on September 25, 2015.    Known lot and expiration date: Lot # 170515 Exp. Date 05/18
The Decree was entered on September 25, 2015.    Known lots and expiration dates: Lot # 260115 Exp. Date 03/18, Lot # 210515 Exp. Date 06/18
The Decree was entered on September 25, 2015.    Known lots and expiration dates: Lot # 040814 Exp. Date 08/17
Bio Moringa Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 110715
The Decree was entered on September 25, 2015.    Known lots and expiration dates: Lot # 510315 Exp. Date 04/18, Lot # 410815 Exp. Date 09/18
Yohimbe Dietary Supplement (unknown container size)
Super Vita Green Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 300615
The Decree was entered on September 25, 2015.    Known lots and expiration dates: Lot # 090414 Exp. Date 05/17, Lot # 100414 Exp. Date 05/17,  Lot # 110414 Exp. Date 05/17, Lot # 040115 Exp. Date 01/18,  Lot # 160315 Exp. Date 04/18, Lot # 190615 Exp. Date 07/18,  Lot # 200615 Exp. Date 07/18
The Decree was entered on September 25, 2015.    Known lot and expiration date: Lot # 450615 Exp. Date 07/18
Anim Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 150515
The Decree was entered on September 25, 2015.    Known lot and expiration date: Lot # 200115 Exp. Date 01/18
The Decree was entered on September 25, 2015.    Known lots and expiration dates: Lot # 370414 Exp. Date 04/17, Lot # 510414 Exp. Date 04/17
Aloe Vera, 25 mg, Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 490814, 141015, 161114, 171114
The Decree was entered on September 25, 2015.    Known lot and expiration date: Lot # 550315 Exp. Date 04/18
The Decree was entered on September 25, 2015.    Known lots and expiration dates: Lot # 370614 Exp. Date 06/17, Lot # 170215 Exp. Date 03/18
The Decree was entered on September 25, 2015.    Known lots and expiration dates: Lot # 120814 Exp. Date 08/17, Lot # 130914 Exp. Date 09/17, Lot # 101014 Exp. Date 11/17, Lot # 330215 Exp. Date 03/18, Lot # 210515 Exp. Date 06/18
Via Sex Dietary Supplement (unknown container size)
Extra Mega Prostamax Dietary Supplement (unknown container size)
Power Max Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 540814, 100815
The Decree was entered on September 25, 2015.    Known lots and expiration dates: Lot # 330514 Exp. Date 06/17, Lot # 420614 Exp. Date 06/17
The Decree was entered on September 25, 2015.    Known lots and expiration dates: Lot # 230714 Exp. Date 07/17, Lot # 260215 Exp. Date 02/18
Denta capsule Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 120415
Growlean Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 490714, 180415
Magic Memory Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 051014
Triphala Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 100215
Natural Fat Burner (45,000 capsule bulk)
The Decree was entered on September 25, 2015.    Known lot and expiration date: Lot # 250715 Exp. Date 07/18
Nem Dietary Supplement (unknown container size)
Colageina 10 Caps, Dietary Supplement (unknown container size)
Tevass Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 080115
Hidroxol Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot and expiration date: Lot # 150414 Exp. Date 04/17
Ashwaganda Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 120215
Sex Power Plus Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 020515
Prostate Plus Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 140715
Marx Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 401214, 411214, 330815
Colon Cleanser Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 310415, 231014
The Decree was entered on September 25, 2015.    Known lots and expiration dates: Lot # 690514 Exp. Date 06/17, Lot # 270814 Exp. Date 09/17, Lot # 111014 Exp. Date 11/17, Lot # 421214 Exp. Date 01/18, Lot # 320315 Exp. Date 05/18
The Decree was entered on September 25, 2015.    Known lots and expiration dates: Lot # 140714 Exp. Date 08/17, Lot # 310914 Exp. Date 10/17, Lot # 560914 Exp. Date 10/17, Lot # 271214 Exp. Date 12/17, Lot # 070115 Exp. Date 01/18, Lot # 460315 Exp. Date 04/18, Lot # 080615 Exp. Date 08/18
Echinacea Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 270215
Saw Palmetto Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 251114, 240614
Blanc Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 381214
The Decree was entered on September 25, 2015.    Known lots and expiration dates: Lot # 400414 Exp. Date 04/17, Lot # 070514 Exp. Date 05/17,  Lot # 100614 Exp. Date 06/17, Lot # 110614 Exp. Date 06/17,  Lot # 120614 Exp. Date 06/17, Lot # 130614 Exp. Date 06/17,   Lot # 140614 Exp. Date 06/17, Lot # 150614 Exp. Date 06/17,  Lot # 130515 Exp. Date 03/18, Lot # 190515 Exp. Date 05/18
The Decree was entered on September 25, 2015.    Known lot and expiration date: Lot # 420315 Exp. Date 03/18
Asey Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 231114, 170315, 310815
The Decree was entered on September 25, 2015.    Known lot and expiration date: Lot # 200614 Exp. Date 07/17
The Decree was entered on September 25, 2015.    Known lots and expiration dates: Lot # 200714 Exp. Date 07/17, Lot # 031214 Exp. Date 12/17, Lot # 291214 Exp. Date 12/17, Lot # 020315 Exp. Date 03/18
Sugar Burner Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 640514
The Decree was entered on September 25, 2015.    Known lot and expiration date: Lot # 140115 Exp. Date 01/18
Glow Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 311214
The Decree was entered on September 25, 2015.    Known lot and expiration date: Lot # 350315 Exp. Date 03/18
The Decree was entered on September 25, 2015.    Known lot and expiration date: Lot # 031014 Exp. Date 10/17
Nees without Aloe Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot and expiration date: Lot # 211014 Exp. Date 10/17
The Decree was entered on September 25, 2015.    Known lot and expiration date: Lot # 040315 Exp. Date 03/18
The Decree was entered on September 25, 2015.    Known lots and expiration dates: Lot # 010414 Exp. Date 04/17, Lot # 140414 Exp. Date 04/17,  Lot # 130514 Exp. Date 05/17, Lot # 430514 Exp. Date 05/17
The Decree was entered on September 25, 2015.    Known lots and expiration dates: Lot # 110814 Exp. Date 08/17, Lot # 330415 Exp. Date 05/18
Diet III Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 221014, 111214, 121214
The Decree was entered on September 25, 2015.    Known lots and expiration dates: Lot # 320414 Exp. Date 05/17, Lot # 590614 Exp. Date 07/17, Lot # 510814 Exp. Date 09/17, Lot # 210914 Exp. Date 09/17, Lot # 540914 Exp. Date 10/17, Lot # 570914 Exp. Date 10/17, Lot # 151014 Exp. Date 11/17, Lot # 350215 Exp. Date 03/18, Lot # 350415 Exp. Date 05/18, Lot # 020115 Exp. Date 01/18
Tyrosine Formula, 90 capsules per bottle
The Decree was entered on September 25, 2015.    Known lots and expiration dates: Lot # 420414 Exp. Date 04/17, Lot # 410615 Exp. Date 06/18
Libene Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 160615
Triflex Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 350414, 171014, 251214, 170115
The Decree was entered on September 25, 2015.    Known lot and expiration date: Lot # 410415 Exp. Date 04/18
Enma Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 260615, 200715, 490815
The Decree was entered on September 25, 2015.    Known lots and expiration dates: Lot # 630514 Exp. Date 05/17, Lot # 050614 Exp. Date 06/17,  Lot # 100315 Exp. Date 04/18
De Pura Fibra Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 220215
Metabolang Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 320514, 620714
Blue Placebo Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 200215
ADAG Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 060715
Proga Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 010914
The Decree was entered on September 25, 2015.    Known lots and expiration dates: Lot # 210714 Exp. Date 07/17, Lot # 041214 Exp. Date 07/17,  Lot # 030315 Exp. Date 03/18, Lot # 051114 Exp. Date 11/17,  Lot # 301214 Exp. Date 12/17
Artrosamin, 250,000 capsules per bulk order
The Decree was entered on September 25, 2015.    Known lots and expiration dates: Lot # 030414 Exp. Date 04/17, Lot # 040414 Exp. Date 04/17,  Lot # 050414 Exp. Date 04/17, Lot # 060414 Exp. Date 04/17,  Lot # 070414 Exp. Date 04/17, Lot # 080414 Exp. Date 04/17,  Lot # 010514 Exp. Date 04/17, Lot # 080514 Exp. Date 04/17,  Lot # 090514 Exp. Date 04/17, Lot # 100514 Exp. Date 05/17,  Lot # 110514 Exp. Date 05/17, Lot # 120514 Exp. Date 05/17,
Welca Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 460615
Gluco + Chond + MSM, Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 060415
The Decree was entered on September 25, 2015.    Known lots and expiration dates: Lot # 021014 Exp. Date 10/17, Lot # 041114 Exp. Date 11/17
Oyster Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 440914
The Decree was entered on September 25, 2015.    Known lots and expiration dates: Lot # 150414 Exp. Date 04/17, Lot # 150414 Exp. Date 04/17, Lot # 150414 Exp. Date 04/17, Lot # 150414 Exp. Date 04/17, Lot # 150414 Exp. Date 04/17, Lot # 150414 Exp. Date 04/17, Lot # 150414 Exp. Date 04/17
The Decree was entered on September 25, 2015.    Known lots and expiration dates: Lot # 210514 Exp. Date 05/17, Lot # 050315 Exp. Date 03/18
Pahaya Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 380315
The Decree was entered on September 25, 2015.    Known lots and expiration dates: Lot # 360614 Exp. Date 07/17, Lot # 251014 Exp. Date 11/17
The Decree was entered on September 25, 2015.    Known lot and expiration date: Lot # 400415 Exp. Date 04/18
The Decree was entered on September 25, 2015.    Known lots and expiration dates: Lot # 630714 Exp. Date 07/17, Lot # 42914 Exp. Date 10/17, Lot # 430914 Exp. Date 10/17, Lot # 10114 Exp. Date 12/17, Lot # 210215 Exp. Date 03/18, Lot # 370515 Exp. Date 06/18, Lot # 050815 Exp. Date 08/18, Lot # 281114 Exp. Date 12/17
The Decree was entered on September 25, 2015.    Known lots and expiration dates: Lot # 220814 Exp. Date 01/17, Lot # 431214 Exp. Date 01/18, Lot # 050415 Exp. Date 05/18, Lot # 100615 Exp. Date 07/18
Nixin Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 370315
Aloe & L Glutamine Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 030814, 230115, 140615
Goji Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 360115, 220515
The Decree was entered on September 25, 2015.    Known lots and expiration dates: Lot # 230514 Exp. Date 06/17, Lot # 330614 Exp. Date 06/17,  Lot # 500714 Exp. Date 09/17, Lot # 510714 Exp. Date 10/17,  Lot # 520714 Exp. Date 11/17, Lot # 360914 Exp. Date 07/18,  Lot # 430814 Exp. Date 08/16, Lot # 450814 Exp. Date 08/14,  Lot # 330914 Exp. Date 09/16, Lot # 340914 Exp. Date 09/16,  Lot # 350914 Exp. Date 09/16, Lot # 370914 Exp. Date 09/16
The Decree was entered on September 25, 2015.    Known lot and expiration date: Lot # 040714 Exp. Date 07/17
The Decree was entered on September 25, 2015.    Known lots and expiration dates: Lot # 340414 Exp. Date 05/17, Lot # 450514 Exp. Date 06/17, Lot # 570614 Exp. Date 06/17, Lot # 230515 Exp. Date 06/18
Prostamax Dietary Supplement (unknown container size)
Super Inmuno Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 061014
Shatavari Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 110215
Nutriplex Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 071014
The Decree was entered on September 25, 2015.    Known lot and expiration date: Lot # 180515 Exp. Date 05/18
Chromium Picolinate Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 030515
The Decree was entered on September 25, 2015.    Known lots and expiration dates: Lot # 310414 Exp. Date 11/17, Lot # 341014 Exp. Date 11/17, Lot # 351014 Exp. Date 11/17, Lot # 050614 Exp. Date 07/18
Nova Life Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 270715
Resvence Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lots and expiration dates: Lot # 420514 Exp. Date 07/17, Lot # 090614 Exp. Date 07/17, Lot # 140814 Exp. Date 09/17, Lot # 150814 Exp. Date 10/17,  Lot # 401014 Exp. Date 11/17, Lot # 340614 Exp. Date 06/17,  Lot # 411014 Exp. Date 11/17
Ginseng Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 040515
The Decree was entered on September 25, 2015.    Known lots and expiration dates: Lot # 390614 Exp. Date 07/17
LIKID Dietary Supplement (unknown container size)
The Decree was entered on September 25, 2015.    Known lot: Lot # 170715, 260815
The Decree was entered on September 25, 2015.    Known lots and expiration dates: Lot # 201014 Exp. Date 10/17, Lot # 130115 Exp. Date 01/18
Product contains undeclared soy lecithin.
Worldwide Distribution - Nationwide Distribution including  US Virgin Island and Puerto Rico , and to the countries of :Japan, Korea, China, Canada, Dominican Republic, Colombia, Chile, Costa Rica, Bahamas, Peru, Panama, Mexico, Argentina, Ecuador, Brazil, Trinidad and Tobago, Hong Kong, Taiwan, United Kingdom, Netherlands, Sri Lanka, Austria, Italy, Germany, United Arab Emirates, Saudi Arabia, Kuwait, France, Belgium, Oman, Ireland, Azerbaijan, India, Spain, Portugal, Luxembourg, Switzerland, Russian Federation, Austria, Greece, Cyprus, Portugal, India, Algeria, Iceland, Iran, Denmark, Hungary, Czech Republic, Ukraine, Turkey, Croatia, Israel, Norway, Oman, Sweden, Libya, Finland, Spain, Portugal, Algeria, Morocco, Poland, Canada, Malaysia, Singapore, Australia, and New Zealand
NIM EMG Endotracheal Tube, 6.0 mm I.D. x 8.8 mm O.D.  (27 FR), Reinforced, Sterile, Rx only. Individually packaged.
Wire in tubing can become exposed, posing potential harm to the intubated patient.
All lots distributed since May 2012.  Catalog Ref No. (reinforced standard tubes) 82-29306, 82-29307, & 82-29308; Catalog Ref No. (reinforced standard tubes, Japan) 8229306J, 8229307J, & 8229308J; Catalot Ref No. (reinforced contact tubes) 8229506, 8229507, & 8229508;
Liquid VITAMIN D-3 Drops distributed under the following private labels and sizes: a) NATURE'S ANSWER VITAMIN D-3 DROPS DIETARY SUPPLEMENT, 0.5 FLUID OZ/15 mL, UPC 8300026132 -- Nature's Answer Hauppauge, NY 11788; and b) Seeking Health Optimal Vitamin D, Liquid Vitamin D-3 Drops, 2000 IU per drop, 1 FL. OZ. (30 ML), UPC 9357376983 -- Manufactured for and distributed by Seeking Health - 3140 Mercer Ave., Bellingham, WA 98225
a) Nature's Answer label: 93,690 bottles; b) Seeking Health label: 70,592 bottles
The lots exceed the label claim for Vitamin D3 of 2000 IU per drop.
NeuViz 64  Multi-slice  CT Scanner Systems
The Firm discovered during contrast agent tracking scan, when the expected concentration of contrast agent is reached, later planned scan may be interrupted. The system must be powered down and restarted to clear the interruption error before scanning can resume.
NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P04 or previous version.    NeuViz 64En, NeuViz 641n with software version 1.0.7.4021+P05 or previous version
NeuViz 128 Multi-slice CT Scanner System with  software version 1.0.7.4038+P06 or previous version
Worldwide Distribution - Nationwide Distribution : and to the countries of : Bermuda, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain and Poland.
VITROS Immunodiagnostic Products Intact PTH Reagent Pack: 1) UPN 10758750006287 / Product Code 6802892 -  Reagent Pack, 2) UPN 10758750006250 / Product Code 6802893 - Calibrators    For the quantitative measurement of intact parathyroid hormone (iPTH) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System. Intact PTH is indicated to aid in the differential diagnosis of hyperparathyroidism, hypoparathyroidism, or hypercalcemia of malignancy and can be used intraoperatively
The device defect is a positive bias of up to 20% relative to the currently marketed Roche device. In addition, the firm states that during the investigation they discovered that the cleared reference interval (RI) was not set optimally at product launch in 2010 and that the upper limit in the IFU of 53.5pg/mL is too low and should be closer to 80 pg/mL. They are in the process of submitting the data to support the revised RI in a new 510K submission and will be changing the IFU once the 510K is cleared.
Techni-Care Surgical Hand Scrub and Patient Preoperative Skin Preparation (3.0% w/v Chloroxylenol), packaged in a) 4 oz. bottles (NDC 46706-201-01), b) 8 oz bottles (NDC 46706-201-02), c) 16 oz. bottles (NDC 46706-201-03), d) 12 oz. pumpette (NDC 46706-201-05), e) 32 oz. bottles (NDC 46706-201-06), OTC, Care-Tech Laboratories, Inc., St. Louis, MO 63139
Labeling: Incorrect or Missing Lot and/or Exp Date - Product is missing or has illegible lot and expiry codes, as well as defective or cracked caps.
Domestic: MI    Foreign: Phillipines    VA/DOD: None
Sterling Diagnostics, Inc.,  Enzymatic Glucose for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previously  extended expiration dates for the kits.
Enzymatic Glucose, CAT No. 2185-L, Lot No. 18561, Expriry: 5/19, Manufactured: 05/25/16
Sterling Diagnostics, Inc., SGPT Colorimetric for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
SGPT Colorimetric, CAT No. 2260-0       , Lot No. 26051, Expriry: 4/18, Manufactured: 04/27/15
Urea Nitrogen/Color BUN (Enzymatic Berthelot) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
Urea Nitrogen/Color BUN, CAT No. 2290-L     , Lot No. 29051, Expriry: 9/18, Manufactured: 09/21/15
Enzymatic Cholesterol (Trinder/COD-CEH) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
Cholesterol, CAT No. 2145-L, Lot No. 14551, Expiry: 11/18, Manufactured: 11/04/15
Sterling Diagnostics, Inc.Colorimetric SGOT for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
Colorimetric SGOT, CAT No. 2250-O, Lot No. 20051, Expriry: 1/19, Manufactured: 01/11/16
Creatinine/Endpoint [Modified Heinegard-Tiderstrom] for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
Creatinine/Endpoint [Modified Heinegard-Tiderstrom], CAT No. 2167-O, Lot No. 16751, Expriry: 5/18, Manufactured: 06/02/15
Sterling Diagnostics, Inc. Serum Iron/IBC (Colorimetric) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
Serum Iron/IBC (Colorimetric), CAT No. 2200-O, Lot No. 20051, Expriry: 5/18, Manufactured: 05/11/15
Sterling Diagnostics, Inc., HDL Cholesterol (PEF Method) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
HDL Cholesterol, CAT No. 2150-P, Lot No. 15051, Expriry: 3/18, Manufactured: 03/10/15
Sterling Diagnostics, Inc., Enzymatic Uric Acid (Uricase Trinder) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
Urea Nitrogen/Color BUN, CAT No. 2305-O     , Lot No. 30551, Expriry: 7/18, Manufactured: 07/21/15
Robusto Ogo  Stored at 70F:  Packed in plastic bags in varying weights from 0.5 lb. to 35 lb.    No codes on product.    Marine Agrifuture, LLC  56-1081 Kamehameha Hwy  Kahuku, HI 96731
Ogo (or Limu) harvested from this farm has been linked to Salmonella illnesses in the state of Hawaii
Kahuko Sea Asparagus  Packed in  clear clamshell in 4 oz.. and 1 lb. weights and 5 lb. plastic bag.     Keep refrigerated/. Rinse or blanch when ready to use.    UPC 4 oz.: 897680001010;  UPC 1 lb.: 897680001027;  UPC 5 lb.: 897680001041.    Marine Agrifuture, LLC  56-1081 Kamehameha Hwy  Kahuku, HI 96731
Kahuko Ogo  Stored at 40F:  Packed in plastic bags in varying weights from 0.5 lb. to 35 lb.    No codes on product.    Marine Agrifuture, LLC  56-1081 Kamehameha Hwy  Kahuku, HI 96731
Alaska, Arizona, California, Colorado, Idaho, Illinois, Kansas, Louisiana, Michigan, Montana, Nebraska, Nevada, New Mexico, Ohio, Oregon, Texas, Utah, and Washington.
Limu Poke is fresh refrigerated product, distributed in bulk kit, net wt. 4.35 lbs.  Each kit includes five individually packages [tuna, onions, limu (ogo seeweed), wet sauce mix, and dry sauce mix].     Each bulk kit is labeled with Costco item #13355.  Costco deli department would upack the kit, mix all five components, repack, and sell at at Costco warehouse stores.
Limu Poke (seaweed tuna) is recalled due to a potential for contamination with Salmonella.  This product contains affected seaweed (Kahuku Ogo) which was recalled by Marine Agrifuture, LLC.
Packed on: November 3, 2016 and November 4, 2016.  Use By: November 5, 2016 and November 6, 2016.
DRIED SILVER FISH, N.W. 30 LBS, PRODUCT OF CHINA
Uneviscerated fish subject to IA 16-74, scheduled for destruction was distributed
CVS pharmacy Kids' Ear Relief Oral Liquid 0.85 oz (25 mL) Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket RI 02895   NDC 59779-687-02 UPC 77815909639
Kids' Relief Ear Relief Oral Liquid 0.85 fl oz. (25 mL)  3025 de'l Assomption Blvd. Montreal, QC H1N 2H2 Canada   NDC 60512-913-8 UPC 77815909639
CVS Health Homeopathic Infants Teething Tablets 135 count bottle  Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 NDC 59779-860-03 UPC 0504284162
Worldwide Distribution - US including CO, FL, GA, IL, MA, MI, NV, NJ, OH, SC, AZ, KY and Internationally to Italy, Ireland, UK, Spain, and Peru
Specimen Gate Laboratory 5002-0180, Specimen Gate eReports 5002-0370, Software Version 1.0  Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data. Specimen Gate eReports Software is a module of Specimen Gate Laboratory that functions to support newborn screening laboratories, hospitals, clinical and physicians in data management and generating reports
Issue may cause eReports to consume an excessive amount of disk space causing the software to stop operating.
Arthex S3 Arm Sleeve Connector; Catalog Number AR-1650-02; manufactured and distributed between March and November 2016.
During use, the unit could separate un-expectantly.  This failure would allow the patient's arm to fall out of suspension during a procedure, possibly causing moderate injury to the patient.  This potential defect is not apparent to the user.
US: TX, NY, SD, PA, MD, OH, IA, IN, MT, IL, FL, SC, OR, CA, AR, GA, CT, NV, PA, NE, WA
Shimadzu X-ray TV System, Catalog No. SONIALVISION G4
Shimadzu Medical Systems is recalling Shimadzu X-ray TV System SONIALVISION due to possibility of oil leaking from the x-ray tube housing under certain conditions.
US Distribution to states of: AZ, WA, CA, LA, FL, SC, and NJ.
Shimadzu X-ray High Voltage Generator Model No. UD150B-40 on SONIALVISION safire II/17 systems with 0.7/1.2JG326D X-Ray Tube    Diagnostic x-ray high voltage generator.
Shimadzu Medical Systems is recalling the Shimadzu X-ray High Voltage Generator due to the possibility of oil leaking from the x-ray tube housing under certain conditions.
US:  AL, AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT,NC, NE NH, NJ, NM, NY, NV, OH, OK, PA, RI, SC, SD, TN, TX,, VA, WA, WO, WY, WV.     OUS:     Algeria  Armenia  Australia  Austria  Brazil  Canada  Chile  China  Denmark  Egypt  France  Germany  Guatemala  Honduras  Hong Kong  Hungary  Iceland  India  Ireland  Italy  Japan  Korea  Libya  Mexico  Netherlands  Netherlands  Peru  Poland  Portugal  Russia  Saudi Arabia  Serbia  Sierra Leone  Slovakia  Spain  Taiwan  Thailand  Turkey  United Arab Emirates  United Kingdom  Venezuela  Vietnam
Total for all products 1,598 (USA 824, OUS 774)
GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 2000 systems.
Mfg. Lot or Serial # System ID  Not Available 1301  Not Available 318783ARF  Not Available 412488F1  Not Available AP3001XR10  Not Available 902567GI  Not Available C4211004  00000048037YY6 PC7281XR02  Not Available PC0731XR01  Not Available A5816801  00000022153YY1 C5304806  00000023739YY6 PL1020RX01  Not Available RU1146RX01
Mfg. Lot or Serial # System ID  00000034206YY3 229353TR2  00000146304MO1 423778ERM4  Not Available 817255NHPD1
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Wilbur; IM10021; B558 Semisweet Chocolate Drops, 2000 CT; Net Weight 50 lb.; This item may contain dairy products; Cargill Cocoa & Chocolate, Inc., Lititz, PA 17543; BATCH 28116AANCB and 28116AANCC    Material number:  100000081    packed in cardboard boxes.
Cargill Cocoa & Chocolate is recalling 50 lb. cartons of Wilbur B558 Semi-Sweet Chocolate Drops because it may contain undeclared milk.
Batch # 28116ANCB and 28116AANCC    material number # 100000081
Nationwide to AL, AR, CA, IL, LA, TX, KY, IN. No Canadian, other foreign, VA/govt/military consignees.
Publix Premium Banana-Flavored Chocolate Chip Pancake & Waffle Mix, 16 oz box.
Milk powder used as ingredient may contain Salmonella.
Publix Premium Pumpkin Pancake & Waffle Mix, 16 oz box.
Publix Premium Blueberry Flavored Pancake & Waffle Mix, 16 oz box.
Kerry Upgrade Bio WS, Net Wt. 50 lb (22068 kg), Item 5R01451.
Upgrade Bio WS has been identified as being adulterated with Bacillus cereus.
Cranberry Orange Scone, brand Mad Batter Bakery, net wt. 5 oz per unit.  Product is sold in a plastic film wrapper with labeling on the back of the package.
Cranberry Orange Scones are recalled because they may contain undeclared Milk, Egg, Soy, and Wheat.
INOVA (benzoyl peroxide) 4%,  Easy Pad (tocopherol) 5%, For topical use only, packaged in a box containing: 30 pads of benzolyl peroxide 3g, 28 capsules of topical tocopherol 5%, OTC, Manufactured for: Innocutis Holdings, LLC, Charleston, SC 29401, NDC 68712-013-01
Subpotent Drug: Product label claim is 4% Benzoyl Peroxide, Initial Stability testing showed variation within the lot outside of product specifications.
Nadolol Tablets, USP, 40mg, packaged in 1000-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540,  NDC 0781-1182-10
Failed dissolution specification: recalled due to an out of specification dissolution result of 40% (Specification: NLT 80%)
VirtPrex Prenatal/Postnatal Tablets, Prescription Supplement Containing Folic Acid and DHA, packaged in 30-count bottle, Rx only, Made in Canada, NDC 76439-348-30
cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
Virt-Select Prenatal/Postnatal Softgels, Prescription Multivitamin/Mineral Dietary Supplement with Fish-Based DHA , packaged in 30-count bottle, Rx only, Made in Canada, NDC 76439-249-30
Virt-Advance Prenatal/Postnatal Softgels, Prescription Folic Acid Containing Dietary Supplement, packaged in 90-count bottle, Rx only, Made in Canada, NDC 76439-357-90
Extra-Virt Plus DHA Prenatal/Postnatal Softgel, Prescription Multivitamin/Mineral Dietary Supplement with Fish-Based DHA , packaged in 30-count bottle, Rx only, Made in Canada, NDC 76439-251-30