Multi-event July 2017 FDA Recall Drug by Ezweightlosstx Llc

This Multi-event Class I drug recall was voluntarily initiated by Ezweightlosstx Llc on July 24, 2017 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0121-2018 TERMINATED D-0122-2018 TERMINATED

Recall Number: D-0121-2018

Reason for Recall
Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplements: products found to be tainted with sibutramine making these unapproved drugs.
Initiated
07-24-2017
Reported
12-27-2017
Quantity
4958 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77817
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.
EZWeightLossTX 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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2021
Product Description About Product Description
Full technical description of the product.
LaBri's Body Health Atomic 60 Capsules Exclusively distributed worldwide by LaBri's Body Health.

Batch or Lot Expiration Information

Lot# All lots remaining within expiry.

Recall Number: D-0122-2018

Reason for Recall
Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplements: products found to be tainted with sibutramine making these unapproved drugs.
Initiated
07-24-2017
Reported
12-27-2017
Quantity
1424 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77817
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.
EZWeightLossTX 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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2021
Product Description About Product Description
Full technical description of the product.
LaBri's Body Health XPLODE 30 capsules Exclusively distribute worldwide by LaBri's Body Health.

Batch or Lot Expiration Information

Lot# All lots remaining within expiry.