Multi-event June 2018 FDA Recall Drug by World Organix, Llc

This Multi-event Class I drug recall was voluntarily initiated by World Organix, Llc on June 26, 2018 for the product Drug. The FDA reported the reason for recall as microbial contamination of non-sterile products. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-1122-2018 TERMINATED D-1126-2018 TERMINATED D-1124-2018 TERMINATED D-1123-2018 TERMINATED D-1125-2018 TERMINATED

Recall Number: D-1122-2018

Reason for Recall
Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.
Initiated
06-26-2018
Reported
08-15-2018
Quantity
789 50-count pouches, total of 39,450 capsules

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80365
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.
World Organix, LLC
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.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-30-2024
Product Description About Product Description
Full technical description of the product.
Blissful Remedies Red Maeng Da, 100% Mitragyna Speciosa capsule, 50-count packaged White Foil Pouche, Dist. by World Organix LLC, Las Vegas, Nevada UPC#7 22589 32355 3

Batch or Lot Expiration Information

Lot# Lot Code: 102710. Best by date: 03/2019

Recall Number: D-1126-2018

Reason for Recall
Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.
Initiated
06-26-2018
Reported
08-15-2018
Quantity
553 50-count pouch, 27,650 capsules

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80365
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.
World Organix, LLC
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.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-30-2024
Product Description About Product Description
Full technical description of the product.
Blissful Remedies Kratom+CBD CBD infused Maeng Da, capsules 50-count packaged in While Foil Pouch. Dist. by World Organix LLC, Las Vegas Nevada UPC# 7 11583 27057 4

Batch or Lot Expiration Information

Lot# Lot Code: 112710 Exp 03/2019

Recall Number: D-1124-2018

Reason for Recall
Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.
Initiated
06-26-2018
Reported
08-15-2018
Quantity
681 12 mL-bottle

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80365
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.
World Organix, LLC
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.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-30-2024
Product Description About Product Description
Full technical description of the product.
Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, 12mL bottle. Distributed by World Organix LLC Las Vegas Nevada. UPC#7 14983 56525 7

Batch or Lot Expiration Information

Lot# Lot Code: 2001. Best by date: 03/2019

Recall Number: D-1123-2018

Reason for Recall
Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.
Initiated
06-26-2018
Reported
08-15-2018
Quantity
164 2oz bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80365
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.
World Organix, LLC
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.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-30-2024
Product Description About Product Description
Full technical description of the product.
Blissful Remedies, 4 Hour Chill, Slow Motion Blend, Herbal Shot. 1.93 Fluid Oz (57ml) UPC#6 02401 88900 3.

Batch or Lot Expiration Information

Lot# Lot Code: 22. Best by date: 06/2019

Recall Number: D-1125-2018

Reason for Recall
Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.
Initiated
06-26-2018
Reported
08-15-2018
Quantity
545 50-count pouches, 27,250 capsules

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80365
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.
World Organix, LLC
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.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-30-2024
Product Description About Product Description
Full technical description of the product.
Blissful Remedies Gold Series Ultra Enhanced Indo, 50 capsule, packaged in While Foil Pouch, Dist. by World Organix LLC, Las Vegas Nevada UPC# 6 02401 88900 2

Batch or Lot Expiration Information

Lot# Lot Code: 112710 Exp 03/2019