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Sundial Herbal Products

11 recall records in Other.

2020

11 records

Class IITerminatedRecall F-1440-2020

Product description

SUNDIAL (4 oz.) ETHIOPIAN TENADAM HERB; "***Strengthens the Vein & Capillaries***lowers high Blood pressure, regulate Heartbeat.***heals Stomach ulcers***"

Reason for recall

Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.

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Event ID
85882
Code info
Product manufactured, processed, packed, held, and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.
Product quantity
Unknown
Distribution pattern
NY
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
3609 Boston Rd, N/A, Bronx, NY, United States
Recall initiation date
06/30/2020
Center classification date
09/15/2020
Termination date
10/26/2022
Class IITerminatedRecall F-1442-2020

Product description

SUNDIAL NIGERIAN MORINGA LEAF POWDER; "***Anti-inflammatory, builds Red Blood cells***" 4oz and 8oz jars

Reason for recall

Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.

View full record
Event ID
85882
Code info
Product manufactured, processed, packed, held, and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.
Product quantity
Unknown
Distribution pattern
NY
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
3609 Boston Rd, N/A, Bronx, NY, United States
Recall initiation date
06/30/2020
Center classification date
09/15/2020
Termination date
10/26/2022
Class IITerminatedRecall F-1445-2020

Product description

Bitter Kola (Arogbo); "***a Natural Antibiotic kills all bacteria, virus, Infections and prevent them***it's a good antidote to all poisons, it's used against stomach problem like EBOLA, Colitis, Diarrhea; dysentery etc. It suppresses the Bacteria that causes them***strengthen immune system with HIV AIDS***"

Reason for recall

Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.

View full record
Event ID
85882
Code info
Product manufactured, processed, packed, held, and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.
Product quantity
Unknown
Distribution pattern
NY
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
3609 Boston Rd, N/A, Bronx, NY, United States
Recall initiation date
06/30/2020
Center classification date
09/15/2020
Termination date
10/26/2022
Class IITerminatedRecall F-1489-2020

Product description

"SUNDIAL***KOROMANTEE***Colonic & Intestinal Cleaner***used by the descendants of the Koromantee people in Jamaica to help cleanse and strengthen the bowels, stomach, intestines, and colonic areas of the body.***" packaged in 16oz glass bottles

Reason for recall

Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.

View full record
Event ID
85882
Code info
Product manufactured, processed, packed, held, and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.
Product quantity
Unknown
Distribution pattern
NY
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
3609 Boston Rd, N/A, Bronx, NY, United States
Recall initiation date
06/30/2020
Center classification date
09/15/2020
Termination date
10/26/2022
Class IITerminatedRecall F-1490-2020

Product description

"***Sundial***ASHANTI**WEIGHT LOSS ENERGY LIFTER and APPETITE SUPPRESSER***" packaged in glass bottles

Reason for recall

Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.

View full record
Event ID
85882
Code info
Product manufactured, processed, packed, held, and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.
Product quantity
Unknown
Distribution pattern
NY
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
3609 Boston Rd, N/A, Bronx, NY, United States
Recall initiation date
06/30/2020
Center classification date
09/15/2020
Termination date
10/26/2022
Class IITerminatedRecall F-1491-2020

Product description

"SUNDIAL***TRADITIONAL AFRICAN MANBACK TONIC***remember the strength of the reproductive organ, reflects the strength of the entire body. Take SUNDIAL AFRICAN MANBACK TONIC to strengthen, rejuvenate & energize***" packaged in glass bottles

Reason for recall

Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.

View full record
Event ID
85882
Code info
Product manufactured, processed, packed, held, and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.
Product quantity
Unknown
Distribution pattern
NY
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
3609 Boston Rd, N/A, Bronx, NY, United States
Recall initiation date
06/30/2020
Center classification date
09/15/2020
Termination date
10/26/2022
Class IITerminatedRecall F-1501-2020

Product description

"SUNDIAL***COCOA BALLS***" packaged in translucent plastic bags

Reason for recall

Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.

View full record
Event ID
85882
Code info
Product manufactured, processed, packed, held, and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.
Product quantity
Unknown
Distribution pattern
NY
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
3609 Boston Rd, N/A, Bronx, NY, United States
Recall initiation date
06/30/2020
Center classification date
09/15/2020
Termination date
10/26/2022
Class IITerminatedRecall F-1502-2020

Product description

"SUNDIAL***ETHIOPIAN ABISH (FENNUGREEK SEED POWDER.)***"

Reason for recall

Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.

View full record
Event ID
85882
Code info
Product manufactured, processed, packed, held, and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.
Product quantity
Unknown
Distribution pattern
NY
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
3609 Boston Rd, N/A, Bronx, NY, United States
Recall initiation date
06/30/2020
Center classification date
09/15/2020
Termination date
10/26/2022
Class IITerminatedRecall F-1504-2020

Product description

"SUNDIAL***Jamaican & Tropical Raw Honey***"

Reason for recall

Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.

View full record
Event ID
85882
Code info
Product manufactured, processed, packed, held, and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.
Product quantity
Unknown
Distribution pattern
NY
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
3609 Boston Rd, N/A, Bronx, NY, United States
Recall initiation date
06/30/2020
Center classification date
09/15/2020
Termination date
10/26/2022
Class IITerminatedRecall F-1505-2020

Product description

"SUNDIAL***Hemp Seed Oil***"

Reason for recall

Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.

View full record
Event ID
85882
Code info
Product manufactured, processed, packed, held, and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.
Product quantity
Unknown
Distribution pattern
NY
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
3609 Boston Rd, N/A, Bronx, NY, United States
Recall initiation date
06/30/2020
Center classification date
09/15/2020
Termination date
10/26/2022
Class IITerminatedRecall F-1506-2020

Product description

"SUNDIAL***Talibah's Tooth Powder***"

Reason for recall

Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.

View full record
Event ID
85882
Code info
Product manufactured, processed, packed, held, and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.
Product quantity
Unknown
Distribution pattern
NY
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
3609 Boston Rd, N/A, Bronx, NY, United States
Recall initiation date
06/30/2020
Center classification date
09/15/2020
Termination date
10/26/2022