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Sunset Natural Products Inc.

173 recall records on file.

2017

20 records

Class IITerminatedRecall F-0959-2017

Product description

Colageina Gold, 195 g Jars

Reason for recall

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.

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Event ID
74054
Code info
As persuant to the Consent Decree, the firm agreed to "recall and destroy, under FDA's supervision, in accordance with the procedures provided in paragraph 6, ALL dietary supplements that were manufactured, prepared, processed, packed, labeled, held and/or distributed between April 2, 2014 and the date of entry of this Decree." 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
Product quantity
10,663 Jars
Distribution pattern
Products distributed to Florida, Nevada and the Dominican Republic
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
7345 SW 45th St, N/A, Miami, FL, United States
Recall initiation date
10/13/2015
Center classification date
12/28/2016
Termination date
04/10/2017
Class IITerminatedRecall F-0960-2017

Product description

Prostaliv, 60 capsules per bottle

Reason for recall

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.

View full record
Event ID
74054
Code info
As persuant to the Consent Decree, the firm agreed to "recall and destroy, under FDA's supervision, in accordance with the procedures provided in paragraph 6, ALL dietary supplements that were manufactured, prepared, processed, packed, labeled, held and/or distributed between April 2, 2014 and the date of entry of this Decree." 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
Product quantity
20,499 Bottles, (1,500,000 capsules)
Distribution pattern
Products distributed to Florida, Nevada and the Dominican Republic
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
7345 SW 45th St, N/A, Miami, FL, United States
Recall initiation date
10/13/2015
Center classification date
12/28/2016
Termination date
04/10/2017
Class IITerminatedRecall F-0961-2017

Product description

Prostaliv New, 60 capsules per bottle

Reason for recall

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.

View full record
Event ID
74054
Code info
As persuant to the Consent Decree, the firm agreed to "recall and destroy, under FDA's supervision, in accordance with the procedures provided in paragraph 6, ALL dietary supplements that were manufactured, prepared, processed, packed, labeled, held and/or distributed between April 2, 2014 and the date of entry of this Decree." 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
Product quantity
15,250 Bottles, (915,000 capsules)
Distribution pattern
Products distributed to Florida, Nevada and the Dominican Republic
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
7345 SW 45th St, N/A, Miami, FL, United States
Recall initiation date
10/13/2015
Center classification date
12/28/2016
Termination date
04/10/2017
Class IITerminatedRecall F-0962-2017

Product description

Moinsage, 60 capsules per bottle

Reason for recall

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.

View full record
Event ID
74054
Code info
As persuant to the Consent Decree, the firm agreed to "recall and destroy, under FDA's supervision, in accordance with the procedures provided in paragraph 6, ALL dietary supplements that were manufactured, prepared, processed, packed, labeled, held and/or distributed between April 2, 2014 and the date of entry of this Decree." 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
Product quantity
28,666 Bottles, (1,720,000 capsules)
Distribution pattern
Products distributed to Florida, Nevada and the Dominican Republic
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
7345 SW 45th St, N/A, Miami, FL, United States
Recall initiation date
10/13/2015
Center classification date
12/28/2016
Termination date
04/10/2017
Class IITerminatedRecall F-0963-2017

Product description

Colageina Orange, (195 g per Jar)

Reason for recall

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.

View full record
Event ID
74054
Code info
As persuant to the Consent Decree, the firm agreed to "recall and destroy, under FDA's supervision, in accordance with the procedures provided in paragraph 6, ALL dietary supplements that were manufactured, prepared, processed, packed, labeled, held and/or distributed between April 2, 2014 and the date of entry of this Decree." 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
Product quantity
5,812 Jar's (195G per Jar)
Distribution pattern
Products distributed to Florida, Nevada and the Dominican Republic
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
7345 SW 45th St, N/A, Miami, FL, United States
Recall initiation date
10/13/2015
Center classification date
12/28/2016
Termination date
04/10/2017
Class IITerminatedRecall F-0964-2017

Product description

Vital Cure, 30 capsules per bottle

Reason for recall

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.

View full record
Event ID
74054
Code info
As persuant to the Consent Decree, the firm agreed to "recall and destroy, under FDA's supervision, in accordance with the procedures provided in paragraph 6, ALL dietary supplements that were manufactured, prepared, processed, packed, labeled, held and/or distributed between April 2, 2014 and the date of entry of this Decree." The Decree was entered on September 25, 2015. Known lots and expiration dates: Lot # 660614, 560714 Exp. Date 07/17, Lot # 090814 Exp. Date 09/17, Lot # 280914 Exp. Date 09/17, Lot # 290914 Exp. Date 10/17, Lot # 261014 Exp. Date 11/17, Lot # 211114 Exp. Date 12/17, Lot # 011214 Exp. Date 12/17, Lot # 280115 Exp. Date 01/18, Lot # 230215 Exp. Date 03/18, Lot # 090315 Exp. Date 03/18, Lot # 520315 Exp. Date 03/18, Lot # 060515 Exp. Date 05/18, Lot # 310515 Exp. Date 06/18, Lot # 380515 Exp. Date 06/18, Lot # 120615 Exp. Date 07/18, Lot # 440615 Exp. Date 06/18, Lot # 090715 Exp. Date 07/18, Lot # 210715 Exp. Date 07/18, Lot # 220715 Exp. Date 08/18, Lot # 230715 Exp. Date 08/18, Lot # 210815 Exp. Date 08/18, Lot # 140415 Exp. Date 04/18
Product quantity
189,533 Bottles, (6,136,000 capsules)
Distribution pattern
Products distributed to Florida, Nevada and the Dominican Republic
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
7345 SW 45th St, N/A, Miami, FL, United States
Recall initiation date
10/13/2015
Center classification date
12/28/2016
Termination date
04/10/2017
Class IITerminatedRecall F-0965-2017

Product description

True Vital, 30 capsules per bottle

Reason for recall

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.

View full record
Event ID
74054
Code info
As persuant to the Consent Decree, the firm agreed to "recall and destroy, under FDA's supervision, in accordance with the procedures provided in paragraph 6, ALL dietary supplements that were manufactured, prepared, processed, packed, labeled, held and/or distributed between April 2, 2014 and the date of entry of this Decree." The Decree was entered on September 25, 2015. Known lot and expiration date: Lot # 130615, 240215 Exp. Date 03/18
Product quantity
1,000 Bottles, (30,000 capsules)
Distribution pattern
Products distributed to Florida, Nevada and the Dominican Republic
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
7345 SW 45th St, N/A, Miami, FL, United States
Recall initiation date
10/13/2015
Center classification date
12/28/2016
Termination date
04/10/2017
Class IITerminatedRecall F-0966-2017

Product description

Pinateina

Reason for recall

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.

View full record
Event ID
74054
Code info
As persuant to the Consent Decree, the firm agreed to "recall and destroy, under FDA's supervision, in accordance with the procedures provided in paragraph 6, ALL dietary supplements that were manufactured, prepared, processed, packed, labeled, held and/or distributed between April 2, 2014 and the date of entry of this Decree." The Decree was entered on September 25, 2015. Known lot and expiration date: Lot # 550315 Exp. Date 04/18
Product quantity
500 Bottles
Distribution pattern
Products distributed to Florida, Nevada and the Dominican Republic
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
7345 SW 45th St, N/A, Miami, FL, United States
Recall initiation date
10/13/2015
Center classification date
12/28/2016
Termination date
04/10/2017
Class IITerminatedRecall F-0967-2017

Product description

Avit, bulk capsules

Reason for recall

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.

View full record
Event ID
74054
Code info
As persuant to the Consent Decree, the firm agreed to "recall and destroy, under FDA's supervision, in accordance with the procedures provided in paragraph 6, ALL dietary supplements that were manufactured, prepared, processed, packed, labeled, held and/or distributed between April 2, 2014 and the date of entry of this Decree." 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
Product quantity
891,000 capsules
Distribution pattern
Products distributed to Florida, Nevada and the Dominican Republic
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
7345 SW 45th St, N/A, Miami, FL, United States
Recall initiation date
10/13/2015
Center classification date
12/28/2016
Termination date
04/10/2017
Class IITerminatedRecall F-0968-2017

Product description

Coclss, bulk capsules

Reason for recall

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.

View full record
Event ID
74054
Code info
As persuant to the Consent Decree, the firm agreed to "recall and destroy, under FDA's supervision, in accordance with the procedures provided in paragraph 6, ALL dietary supplements that were manufactured, prepared, processed, packed, labeled, held and/or distributed between April 2, 2014 and the date of entry of this Decree." 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
Product quantity
2,400,000 capsules
Distribution pattern
Products distributed to Florida, Nevada and the Dominican Republic
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
7345 SW 45th St, N/A, Miami, FL, United States
Recall initiation date
10/13/2015
Center classification date
12/28/2016
Termination date
04/10/2017
Class IITerminatedRecall F-0969-2017

Product description

Zinc Gluconate, bulk capsules

Reason for recall

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.

View full record
Event ID
74054
Code info
As persuant to the Consent Decree, the firm agreed to "recall and destroy, under FDA's supervision, in accordance with the procedures provided in paragraph 6, ALL dietary supplements that were manufactured, prepared, processed, packed, labeled, held and/or distributed between April 2, 2014 and the date of entry of this Decree." 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
Product quantity
1,540,000 capsules
Distribution pattern
Products distributed to Florida, Nevada and the Dominican Republic
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
7345 SW 45th St, N/A, Miami, FL, United States
Recall initiation date
10/13/2015
Center classification date
12/28/2016
Termination date
04/10/2017
Class IITerminatedRecall F-0970-2017

Product description

Karma, bulk capsules

Reason for recall

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.

View full record
Event ID
74054
Code info
As persuant to the Consent Decree, the firm agreed to "recall and destroy, under FDA's supervision, in accordance with the procedures provided in paragraph 6, ALL dietary supplements that were manufactured, prepared, processed, packed, labeled, held and/or distributed between April 2, 2014 and the date of entry of this Decree." The Decree was entered on September 25, 2015. Known lot and expiration date: Lot # 150414 Exp. Date 04/17
Product quantity
65,000 capsules
Distribution pattern
Products distributed to Florida, Nevada and the Dominican Republic
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
7345 SW 45th St, N/A, Miami, FL, United States
Recall initiation date
10/13/2015
Center classification date
12/28/2016
Termination date
04/10/2017
Class IITerminatedRecall F-0971-2017

Product description

Aloe Vera 500 mg, bulk capsules

Reason for recall

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.

View full record
Event ID
74054
Code info
As persuant to the Consent Decree, the firm agreed to "recall and destroy, under FDA's supervision, in accordance with the procedures provided in paragraph 6, ALL dietary supplements that were manufactured, prepared, processed, packed, labeled, held and/or distributed between April 2, 2014 and the date of entry of this Decree." The Decree was entered on September 25, 2015. Known lots and expiration dates: Lot # 170414 Exp. Date 05/17, Lot # 260414 Exp. Date 05/17, Lot # 270414 Exp. Date 05/17, Lot # 430414 Exp. Date 05/17, Lot # 440414 Exp. Date 07/17, Lot # 450414 Exp. Date 06/17, Lot # 170514 Exp. Date 06/17, Lot # 180514 Exp. Date 06/17, Lot # 340514 Exp. Date 08/17, Lot # 350514 Exp. Date 08/17, Lot # 360514 Exp. Date 09/17, Lot # 370514 Exp. Date 08/17, Lot # 050814 Exp. Date 09/17, Lot # 060814 Exp. Date 10/17, Lot # 070814 Exp. Date 10/17, Lot # 080814 Exp. Date 10/17, Lot # 030914 Exp. Date 10/17, Lot # 040914 Exp. Date 10/17, Lot # 050914 Exp. Date 10/17, Lot # 060914 Exp. Date 10/17, Lot # 190914 Exp. Date 09/17, Lot # 220914 Exp. Date 09/17, Lot # 240914 Exp. Date 09/17, Lot # 380914 Exp. Date 10/17, Lot # 390914 Exp. Date 11/17, Lot # 400914 Exp. Date 11/17, Lot # 410914 Exp. Date 11/17, Lot # 501014 Exp. Date 11/17, Lot # 511014 Exp. Date 11/17, Lot # 521014 Exp. Date 11/17, Lot # 531014 Exp. Date 11/17
Product quantity
12,310,000 capsules
Distribution pattern
Products distributed to Florida, Nevada and the Dominican Republic
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
7345 SW 45th St, N/A, Miami, FL, United States
Recall initiation date
10/13/2015
Center classification date
12/28/2016
Termination date
04/10/2017
Class IITerminatedRecall F-0972-2017

Product description

Mecogm, bulk capsules

Reason for recall

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.

View full record
Event ID
74054
Code info
As persuant to the Consent Decree, the firm agreed to "recall and destroy, under FDA's supervision, in accordance with the procedures provided in paragraph 6, ALL dietary supplements that were manufactured, prepared, processed, packed, labeled, held and/or distributed between April 2, 2014 and the date of entry of this Decree." 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
Product quantity
1,155,000 capsules
Distribution pattern
Products distributed to Florida, Nevada and the Dominican Republic
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
7345 SW 45th St, N/A, Miami, FL, United States
Recall initiation date
10/13/2015
Center classification date
12/28/2016
Termination date
04/10/2017
Class IITerminatedRecall F-0973-2017

Product description

Wesmag, bulk capsules

Reason for recall

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.

View full record
Event ID
74054
Code info
As persuant to the Consent Decree, the firm agreed to "recall and destroy, under FDA's supervision, in accordance with the procedures provided in paragraph 6, ALL dietary supplements that were manufactured, prepared, processed, packed, labeled, held and/or distributed between April 2, 2014 and the date of entry of this Decree." 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
Product quantity
408,000 capsules
Distribution pattern
Products distributed to Florida, Nevada and the Dominican Republic
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
7345 SW 45th St, N/A, Miami, FL, United States
Recall initiation date
10/13/2015
Center classification date
12/28/2016
Termination date
04/10/2017
Class IITerminatedRecall F-0974-2017

Product description

Horny Goat Weed, bulk capsules

Reason for recall

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.

View full record
Event ID
74054
Code info
As persuant to the Consent Decree, the firm agreed to "recall and destroy, under FDA's supervision, in accordance with the procedures provided in paragraph 6, ALL dietary supplements that were manufactured, prepared, processed, packed, labeled, held and/or distributed between April 2, 2014 and the date of entry of this Decree." 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
Product quantity
1,100,000
Distribution pattern
Products distributed to Florida, Nevada and the Dominican Republic
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
7345 SW 45th St, N/A, Miami, FL, United States
Recall initiation date
10/13/2015
Center classification date
12/28/2016
Termination date
04/10/2017
Class IITerminatedRecall F-0975-2017

Product description

Bima, bulk capsules

Reason for recall

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.

View full record
Event ID
74054
Code info
As persuant to the Consent Decree, the firm agreed to "recall and destroy, under FDA's supervision, in accordance with the procedures provided in paragraph 6, ALL dietary supplements that were manufactured, prepared, processed, packed, labeled, held and/or distributed between April 2, 2014 and the date of entry of this Decree." 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
Product quantity
550,000 capsules
Distribution pattern
Products distributed to Florida, Nevada and the Dominican Republic
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
7345 SW 45th St, N/A, Miami, FL, United States
Recall initiation date
10/13/2015
Center classification date
12/28/2016
Termination date
04/10/2017
Class IITerminatedRecall F-0976-2017

Product description

Arganine & Pine Bark, bulk capsules

Reason for recall

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.

View full record
Event ID
74054
Code info
As persuant to the Consent Decree, the firm agreed to "recall and destroy, under FDA's supervision, in accordance with the procedures provided in paragraph 6, ALL dietary supplements that were manufactured, prepared, processed, packed, labeled, held and/or distributed between April 2, 2014 and the date of entry of this Decree." 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
Product quantity
1,335,000 capsules
Distribution pattern
Products distributed to Florida, Nevada and the Dominican Republic
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
7345 SW 45th St, N/A, Miami, FL, United States
Recall initiation date
10/13/2015
Center classification date
12/28/2016
Termination date
04/10/2017
Class IITerminatedRecall F-0977-2017

Product description

Yaco Capsules, bulk capsules

Reason for recall

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.

View full record
Event ID
74054
Code info
As persuant to the Consent Decree, the firm agreed to "recall and destroy, under FDA's supervision, in accordance with the procedures provided in paragraph 6, ALL dietary supplements that were manufactured, prepared, processed, packed, labeled, held and/or distributed between April 2, 2014 and the date of entry of this Decree." The Decree was entered on September 25, 2015. Known lots and expiration dates: Lot # 470414 Exp. Date 05/17, Lot # 420714 Exp. Date 10/17, Lot # 020914 Exp. Date 11/17, Lot # 231214 Exp. Date 12/17, Lot # 470414 Exp. Date 12/17, Lot # 420714 Exp. Date 01/18, Lot # 020914 Exp. Date 01/18, Lot # 231214 Exp. Date 03/18, Lot # 470414 Exp. Date 04/18, Lot # 420714 Exp. Date 05/18, Lot # 020914 Exp. Date 06/18, Lot # 231214 Exp. Date 06/18, Lot # 470414 Exp. Date 09/18, Lot # 420714 Exp. Date 07/18, Lot # 020914 Exp. Date 08/18
Product quantity
3,900,000
Distribution pattern
Products distributed to Florida, Nevada and the Dominican Republic
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
7345 SW 45th St, N/A, Miami, FL, United States
Recall initiation date
10/13/2015
Center classification date
12/28/2016
Termination date
04/10/2017
Class IITerminatedRecall F-0978-2017

Product description

Colon Therapy, bulk capsules

Reason for recall

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.

View full record
Event ID
74054
Code info
As persuant to the Consent Decree, the firm agreed to "recall and destroy, under FDA's supervision, in accordance with the procedures provided in paragraph 6, ALL dietary supplements that were manufactured, prepared, processed, packed, labeled, held and/or distributed between April 2, 2014 and the date of entry of this Decree." The Decree was entered on September 25, 2015. Known lots and expiration dates: Lot # 020514 Exp. Date 05/17, Lot # 030514 Exp. Date 05/17, Lot # 040514 Exp. Date 05/17, Lot # 140514 Exp. Date 06/17, Lot # 150514 Exp. Date 06/17, Lot # 440514 Exp. Date 05/17, Lot # 500514 Exp. Date 05/17, Lot # 510514 Exp. Date 05/17, Lot # 520514 Exp. Date 05/17, Lot # 530514 Exp. Date 05/17, Lot # 540514 Exp. Date 06/17, Lot # 550514 Exp. Date 06/17, Lot # 560514 Exp. Date 06/17, Lot # 570514 Exp. Date 06/17, Lot # 580514 Exp. Date 06/17, Lot # 590514 Exp. Date 06/17, Lot # 600514 Exp. Date 06/17, Lot # 600514 Exp. Date 06/17, Lot # 610514 Exp. Date 06/17, Lot # 620514 Exp. Date 07/17, Lot # 020714 Exp. Date 07/17, Lot # 240714 Exp. Date 07/17,Lot # 250714 Exp. Date 07/17, Lot # 260714 Exp. Date 07/17, Lot # 270714 Exp. Date 07/17, Lot # 280714 Exp. Date 07/17, Lot # 290714 Exp. Date 07/17, Lot # 300714 Exp. Date 07/17, Lot # 310714 Exp. Date 08/17, Lot # 320714 Exp. Date 08/17, Lot # 330714 Exp. Date 08/17, Lot # 340714 Exp. Date 08/17, Lot # 350714 Exp. Date 08/17, Lot # 380714 Exp. Date 09/17, Lot # 390714 Exp. Date 09/17, Lot # 400714 Exp. Date 09/17, Lot # 410714 Exp. Date 10/17, Lot # 280814 Exp. Date 10/17, Lot # 290814 Exp. Date 10/17, Lot # 300814 Exp. Date 10/17, Lot # 310814 Exp. Date 10/17, Lot # 320814 Exp. Date 10/17, Lot # 230914 Exp. Date 09/17, Lot # 270914 Exp. Date 10/17, Lot # 081014 Exp. Date 11/17, Lot # 091014 Exp. Date 11/17, Lot # 020615 Exp. Date 07/18, Lot # 040615 Exp. Date 07/18, Lot # 170615 Exp. Date 07/18, Lot # 180615 Exp. Date 08/18, Lot # 390615 Exp. Date 08/18, Lot # 480615 Exp. Date 08/18, Lot # 160715 Exp. Date 07/18
Product quantity
19,455,300
Distribution pattern
Products distributed to Florida, Nevada and the Dominican Republic
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
7345 SW 45th St, N/A, Miami, FL, United States
Recall initiation date
10/13/2015
Center classification date
12/28/2016
Termination date
04/10/2017