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Sunset Natural Products Inc.

173 recall records on file.

2017

3 records

Class IITerminatedRecall F-1079-2017

Product description

De Pura Fibra Dietary Supplement (unknown container size)

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 lot: Lot # 220215
Product quantity
Unknown
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-1080-2017

Product description

Glow Dietary Supplement (unknown container size)

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: Lot # 311214
Product quantity
Unknown
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-1081-2017

Product description

Diet III Dietary Supplement (unknown container size)

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: Lot # 221014, 111214, 121214
Product quantity
Unknown
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

2016

10 records

Class IITerminatedRecall F-0536-2016

Product description

Abee Med, 60 capsules per bottle. Manufactured by Sunset Natural Products

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 manufatured 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
72877
Code info
Lot # 420415 Exp. Date 04/18 UPC 850993004017
Product quantity
3,149 bottles (240,000 caps)
Distribution pattern
FL and NV
Voluntary / mandated
FDA Mandated
Initial firm notification
Other
Product type
Food
Recalling firm location
7345 SW 45th St, Miami, FL, United States
Recall initiation date
10/05/2015
Center classification date
02/17/2016
Termination date
04/10/2017
Class IITerminatedRecall F-0537-2016

Product description

Argindione, sold as bulk of 50,000 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 manufatured 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
72877
Code info
Lot # 480514 Exp. Date 05/17 and Lot # 320614 Exp. Date 06/17
Product quantity
100,000 capsules
Distribution pattern
FL and NV
Voluntary / mandated
FDA Mandated
Initial firm notification
Other
Product type
Food
Recalling firm location
7345 SW 45th St, Miami, FL, United States
Recall initiation date
10/05/2015
Center classification date
02/17/2016
Termination date
04/10/2017
Class IITerminatedRecall F-0538-2016

Product description

Chardon de Marie, 60 capsules per bottle. Manufactured by Sunset Natural Products

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 manufatured 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
72877
Code info
Lot # 141214 Exp. Date 12/17 UPC 897666001157
Product quantity
3,260 bottles (200,000 caps)
Distribution pattern
FL and NV
Voluntary / mandated
FDA Mandated
Initial firm notification
Other
Product type
Food
Recalling firm location
7345 SW 45th St, Miami, FL, United States
Recall initiation date
10/05/2015
Center classification date
02/17/2016
Termination date
04/10/2017
Class IITerminatedRecall F-0539-2016

Product description

Moinsage, 60 capsules per bottle. Manufactured by Sunset Natural Products

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 manufatured 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
72877
Code info
Lot # 030615 Exp. Date 07/18 UPC 897666001164
Product quantity
5,000 bottles (300,000 caps)
Distribution pattern
FL and NV
Voluntary / mandated
FDA Mandated
Initial firm notification
Other
Product type
Food
Recalling firm location
7345 SW 45th St, Miami, FL, United States
Recall initiation date
10/05/2015
Center classification date
02/17/2016
Termination date
04/10/2017
Class IITerminatedRecall F-0540-2016

Product description

Neuro-Cetin, sold in bulk 50,000 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 manufatured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.

View full record
Event ID
72877
Code info
Lot # 110315 Exp. Date 04/18
Product quantity
50,000 capsules
Distribution pattern
FL and NV
Voluntary / mandated
FDA Mandated
Initial firm notification
Other
Product type
Food
Recalling firm location
7345 SW 45th St, Miami, FL, United States
Recall initiation date
10/05/2015
Center classification date
02/17/2016
Termination date
04/10/2017
Class IITerminatedRecall F-0541-2016

Product description

Prostaliv, 60 capsules per bottle. Manufactured by Sunset Natural Products

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 manufatured 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
72877
Code info
Lot # 180215 Exp Date 02/18 UPC 897666001144,
Product quantity
5000 bottles (300,000)
Distribution pattern
FL and NV
Voluntary / mandated
FDA Mandated
Initial firm notification
Other
Product type
Food
Recalling firm location
7345 SW 45th St, Miami, FL, United States
Recall initiation date
10/05/2015
Center classification date
02/17/2016
Termination date
04/10/2017
Class IITerminatedRecall F-0542-2016

Product description

Prostamax DUO, 60 capsules per bottle. Manufactured by Sunset Natural Products

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 manufatured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.

View full record
Event ID
72877
Code info
Lot # 140515 Exp. Date 05/18 UPC 850993004055,
Product quantity
4,000 bottles (240,000 capsules)
Distribution pattern
FL and NV
Voluntary / mandated
FDA Mandated
Initial firm notification
Other
Product type
Food
Recalling firm location
7345 SW 45th St, Miami, FL, United States
Recall initiation date
10/05/2015
Center classification date
02/17/2016
Termination date
04/10/2017
Class IITerminatedRecall F-0543-2016

Product description

Prostax Forte, sold in bulk of 50,000 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 manufatured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.

View full record
Event ID
72877
Code info
Lot # 120315 Exp. Date 03/18
Product quantity
50,000 capsules
Distribution pattern
FL and NV
Voluntary / mandated
FDA Mandated
Initial firm notification
Other
Product type
Food
Recalling firm location
7345 SW 45th St, Miami, FL, United States
Recall initiation date
10/05/2015
Center classification date
02/17/2016
Termination date
04/10/2017
Class IITerminatedRecall F-0544-2016

Product description

Venocell, sold in bulk of 50,000 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 manufatured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.

View full record
Event ID
72877
Code info
Lot # 160614 Exp. Date 06/17 and Lot # 490914 Exp. Date 10/17
Product quantity
100,000 capsules
Distribution pattern
FL and NV
Voluntary / mandated
FDA Mandated
Initial firm notification
Other
Product type
Food
Recalling firm location
7345 SW 45th St, Miami, FL, United States
Recall initiation date
10/05/2015
Center classification date
02/17/2016
Termination date
04/10/2017
Class IITerminatedRecall F-0617-2016

Product description

Hepasil, sold in bulk of 500,000 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 manufatured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.

View full record
Event ID
72877
Code info
Lot # 080315 Exp. Date 03/18
Product quantity
500,000 capsules
Distribution pattern
FL and NV
Voluntary / mandated
FDA Mandated
Initial firm notification
Other
Product type
Food
Recalling firm location
7345 SW 45th St, Miami, FL, United States
Recall initiation date
10/05/2015
Center classification date
02/17/2016
Termination date
04/10/2017