Multi-event December 2015 FDA Recall Drug by Bee Xtreme

This Multi-event Class I drug recall was voluntarily initiated by Bee Xtreme on December 23, 2015 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda; fda analysis found them to contain sibutramine and phenolphthalein. The product was distributed in Unknown and the recall is currently terminated.

Reported Recall Events

D-0019-2017 TERMINATED D-0021-2017 TERMINATED D-0020-2017 TERMINATED

Recall Number: D-0019-2017

Reason for Recall
Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolphthalein
Initiated
12-23-2015
Reported
10-19-2016
Quantity
589 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73167
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.
Bee Xtreme
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Unknown
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-30-2017
Product Description About Product Description
Full technical description of the product.
La' Trim Plus Dietary Supplement Capsules, 350 mg, 60 count bottles, Manufactured for Timeless Solutions, 1810 E Sahara Ave #100, Las Vegas, Nevada 89104, distributed by BeeXtreme LLC, Punxsutawney PA

Batch or Lot Expiration Information

Lot# All Lots

Recall Number: D-0021-2017

Reason for Recall
Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolphthalein
Initiated
12-23-2015
Reported
10-19-2016
Quantity
13 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73167
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.
Bee Xtreme
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Unknown
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-30-2017
Product Description About Product Description
Full technical description of the product.
Jenesis Dietary Supplement Capsules, 350 mg, 60 count bottles, Manufactured for Timeless Solutions, 1810 E Sahara Ave #100, Las Vegas, Nevada 89104, distributed by BeeXtreme LLC, Punxsutawney PA

Batch or Lot Expiration Information

Lot# All Lots

Recall Number: D-0020-2017

Reason for Recall
Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolphthalein
Initiated
12-23-2015
Reported
10-19-2016
Quantity
732 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73167
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.
Bee Xtreme
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Unknown
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-30-2017
Product Description About Product Description
Full technical description of the product.
Oasis Dietary Supplement Capsules, 500 mg, 45 count bottles, Manufactured for Timeless Solutions, 1810 E Sahara Ave #100, Las Vegas, Nevada 89104, distributed by BeeXtreme LLC, Punxsutawney PA

Batch or Lot Expiration Information

Lot# All Lots