Multi-event February 2019 FDA Recall Drug by Todd Holiday Dba Sunstone Organics

This Multi-event Class I drug recall was voluntarily initiated by Todd Holiday Dba Sunstone Organics on February 13, 2019 for the product Drug. The FDA reported the reason for recall as microbial contamination of non-sterile products. The product was distributed in California, Nebraska, Oregon, Washington and the recall is currently terminated.

Reported Recall Events

D-0989-2019 TERMINATED D-0987-2019 TERMINATED D-0988-2019 TERMINATED D-0986-2019 TERMINATED

Recall Number: D-0989-2019

Reason for Recall
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.
Initiated
02-13-2019
Reported
03-13-2019
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82247
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Todd Holiday dba Sunstone Organics
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
California, Nebraska, Oregon, Washington
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-14-2023
Product Description About Product Description
Full technical description of the product.
Maeng Da Kratom, packaged in a) 20 count capsules (UPC 00859667007149), b) 60 count capsules (UPC 00859667007156), c) 150 count capsules (UPC 00859667007163) , Sunstone Organics Springfield, Oregon 97473, 541-972-3327.

Batch or Lot Expiration Information

Lot# 124A

Recall Number: D-0987-2019

Reason for Recall
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.
Initiated
02-13-2019
Reported
03-13-2019
Quantity
250 Kilograms

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82247
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Todd Holiday dba Sunstone Organics
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
California, Nebraska, Oregon, Washington
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-14-2023
Product Description About Product Description
Full technical description of the product.
White Vein Kratom, packaged in a) 25 gram powder (UPC 00859667007316), b) 50 gram powder (UPC 00859667007323), c) 100 gram powder (UPC 00859667007330), Sunstone Organics Springfield, Oregon 97473, 541-972-3327.

Batch or Lot Expiration Information

Lot# 119

Recall Number: D-0988-2019

Reason for Recall
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.
Initiated
02-13-2019
Reported
03-13-2019
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82247
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Todd Holiday dba Sunstone Organics
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
California, Nebraska, Oregon, Washington
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-14-2023
Product Description About Product Description
Full technical description of the product.
White Vein Kratom, packaged in a) 20 count capsules (UPC 00859667007347), b) 60 count capsules (UPC 00859667007354), c) 150 count capsules (UPC 00859667007361), Sunstone Organics Springfield, Oregon 97473 541-972-3327.

Batch or Lot Expiration Information

Lot# 119

Recall Number: D-0986-2019

Reason for Recall
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.
Initiated
02-13-2019
Reported
03-13-2019
Quantity
800 kilograms

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82247
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Todd Holiday dba Sunstone Organics
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
California, Nebraska, Oregon, Washington
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-14-2023
Product Description About Product Description
Full technical description of the product.
Maeng Da Kratom, packaged in a) 25 gram powder (UPC 00859667007118), b) 50 gram powder (UPC 00859667007125), c) 100 gram powder (UPC 00859667007132), Sunstone Organics Springfield, Oregon 97473, 541-972-3327.

Batch or Lot Expiration Information

Lot# 124A