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Sunset Natural Products Inc.

173 recall records on file.

2017

20 records

Class IITerminatedRecall F-0929-2017

Product description

Collagen & VIT C, 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.

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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 # 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
Product quantity
23,100 Bottles (1,364,000 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-0930-2017

Product description

Colostrum, 90 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 # 201014 Exp. Date 10/17, Lot # 130115 Exp. Date 01/18
Product quantity
288 Bottles (26,000 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-0931-2017

Product description

Joint I, 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 lot and expiration date: Lot # 140115 Exp. Date 01/18
Product quantity
36 Bottles (12,400 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-0932-2017

Product description

Liver Energy, 100 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 # 200115 Exp. Date 01/18
Product quantity
124 Bottles (18,000 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-0933-2017

Product description

Artrosamin, 250,000 capsules per bulk order

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 # 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,
Product quantity
3,000,000 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-0934-2017

Product description

Hepasil, (various bulk amounts)

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 # 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
Product quantity
2,650,000 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-0935-2017

Product description

Argindione, (50,000 capsule bulk)

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 # 520414 Exp. Date 04/17
Product quantity
50,000 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-0936-2017

Product description

Dygeszyme, (50,000 capsule bulk)

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 # 630514 Exp. Date 05/17, Lot # 050614 Exp. Date 06/17, Lot # 100315 Exp. Date 04/18
Product quantity
150,000 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-0937-2017

Product description

Prostax Forte, (50,000 capsule bulk)

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 # 300614 Exp. Date 06/17, Lot # 480614 Exp. Date 10/17
Product quantity
100,000 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-0938-2017

Product description

Magnumn, (30 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 # 040315 Exp. Date 03/18
Product quantity
400 Bottles, (30 per bottle)
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-0939-2017

Product description

Magnun Plus, (30 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 # 210514 Exp. Date 05/17, Lot # 050315 Exp. Date 03/18
Product quantity
900 Bottles (27,000 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-0950-2017

Product description

Equs, (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 # 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
Product quantity
1800 bottles, (54,000 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-0951-2017

Product description

Equs Mas, (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 # 200714 Exp. Date 07/17, Lot # 031214 Exp. Date 12/17, Lot # 291214 Exp. Date 12/17, Lot # 020315 Exp. Date 03/18
Product quantity
1,600 Bottles, (48,000 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-0952-2017

Product description

Lebytol, 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 # 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
Product quantity
2,400 Bottles, (72,000 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-0953-2017

Product description

ABS Reducer, 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 lot and expiration date: Lot # 340315 Exp. Date 03/18
Product quantity
2,000 Bottles, (120,000 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-0954-2017

Product description

Weight Control, 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 lot and expiration date: Lot # 250115 Exp. Date 01/18
Product quantity
2000 Bottles, (35,000 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-0955-2017

Product description

Nutrigen, 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 # 260115 Exp. Date 03/18, Lot # 210515 Exp. Date 06/18
Product quantity
3,000 Bottles, (180,000 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-0956-2017

Product description

Weight 2.0, 120 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 # 350315 Exp. Date 03/18
Product quantity
1,000 Bottles, (120,000 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-0957-2017

Product description

Tyrosine Formula, 90 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 # 420414 Exp. Date 04/17, Lot # 410615 Exp. Date 06/18
Product quantity
250 Bottles, ( 22,500 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-0958-2017

Product description

Chardon De Marie, 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 # 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
Product quantity
23,665 Bottles, (1,420,000 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