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Sunset Natural Products Inc.

173 recall records on file.

2017

20 records

Class IITerminatedRecall F-0979-2017

Product description

Haga, 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.

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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 # 330514 Exp. Date 06/17, Lot # 420614 Exp. Date 06/17
Product quantity
70,000 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-0980-2017

Product description

Prusha, 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 # 380514 Exp. Date 05/17
Product quantity
60,000 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-0981-2017

Product description

Memory, 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 # 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
Product quantity
2,040,000 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-0982-2017

Product description

Ginko Biloba 150 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 # 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
Product quantity
900,000 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-0983-2017

Product description

Alri, 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 # 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
Product quantity
380,000 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-0984-2017

Product description

Seral, 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 # 010614 Exp. Date 06/17, Lot # 520914 Exp. Date 10/17, Lot # 530914 Exp. Date 10/17, Lot # 181114 Exp. Date 12/17
Product quantity
900,000 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-0985-2017

Product description

Garcro, 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 # 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
Product quantity
1,530,000 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-0986-2017

Product description

Gludo, 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 # 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
Product quantity
1,530,000
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-0987-2017

Product description

Strev, 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 # 040614 Exp. Date 07/17
Product quantity
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-0988-2017

Product description

Kelp Acerola & Green Tea, 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 # 170614 Exp. Date 08/17, Lot # 200515 Exp. Date 06/18
Product quantity
330,000 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-0989-2017

Product description

Bees, 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 # 200614 Exp. Date 07/17
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-0990-2017

Product description

Horsil, 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 # 360614 Exp. Date 07/17, Lot # 251014 Exp. Date 11/17
Product quantity
330,000 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-0991-2017

Product description

Foni, 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 # 370614 Exp. Date 06/17, Lot # 170215 Exp. Date 03/18
Product quantity
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-0992-2017

Product description

Ramto, 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 # 430614 Exp. Date 06/17, Lot # 440614 Exp. Date 06/17, Lot # 460614 Exp. Date 07/17, Lot # 470614 Exp. Date 07/17, Lot # 480614 Exp. Date 07/17, Lot # 500614 Exp. Date 07/17, Lot # 510614 Exp. Date 07/17, Lot # 520614 Exp. Date 07/17, Lot # 530614 Exp. Date 07/17, Lot # 540614 Exp. Date 07/17, Lot # 550614 Exp. Date 07/17, Lot # 560614 Exp. Date 07/17, Lot # 055714 Exp. Date 08/17, Lot # 060714 Exp. Date 08/17, Lot # 070714 Exp. Date 08/17, Lot # 080714 Exp. Date 08/17, Lot # 470914 Exp. Date 10/17, Lot # 550914 Exp. Date 10/17, Lot # 380115 Exp. Date 02/18, Lot # 190315 Exp. Date 03/18, Lot # 200315 Exp. Date 03/18
Product quantity
9,290,000
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-0993-2017

Product description

Abte, 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 # 040714 Exp. Date 07/17
Product quantity
60,000 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-0994-2017

Product description

DHEA 25 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 # 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
Product quantity
1,444,900 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-0995-2017

Product description

Aloe Vera & Lecithin, 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 # 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
Product quantity
1,457,000
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-0996-2017

Product description

Resin, 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 # 040814 Exp. Date 08/17
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-0997-2017

Product description

Nees, 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 # 110814 Exp. Date 08/17, Lot # 330415 Exp. Date 05/18
Product quantity
95,000 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-0998-2017

Product description

Murine, 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 # 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
Product quantity
1,710,000 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