Multi-event October 2013 FDA Recall Drug by Pure Edge Nutrition

This Multi-event Class I drug recall was voluntarily initiated by Pure Edge Nutrition on October 10, 2013 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda; product was found to contain undeclared sibutramine & phenolphthalein. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-1367-2014 TERMINATED D-1368-2014 TERMINATED D-1366-2014 TERMINATED D-1369-2014 TERMINATED D-1370-2014 TERMINATED D-1365-2014 TERMINATED

Recall Number: D-1367-2014

Reason for Recall
Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein
Initiated
10-10-2013
Reported
06-18-2014
Quantity
unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67810
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.
Pure Edge Nutrition
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.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-07-2016
Product Description About Product Description
Full technical description of the product.
Bella Vi BTrim ULTIMATE BOOST Dietary Supplement capsules, 30 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ

Batch or Lot Expiration Information

Lot# BTRM3452 EXP: 2015/07/03

Recall Number: D-1368-2014

Reason for Recall
Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein
Initiated
10-10-2013
Reported
06-18-2014
Quantity
unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67810
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.
Pure Edge Nutrition
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.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-07-2016
Product Description About Product Description
Full technical description of the product.
Bella Vi eXtreme ACCELERATOR Dietary Supplement Capsules, 30 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ

Batch or Lot Expiration Information

Lot# BTRX7654 EXP: 2015/07/08

Recall Number: D-1366-2014

Reason for Recall
Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein
Initiated
10-10-2013
Reported
06-18-2014
Quantity
unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67810
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.
Pure Edge Nutrition
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.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-07-2016
Product Description About Product Description
Full technical description of the product.
Bella Vi BTrim MAX Dietary Supplement capsules, 60 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ

Batch or Lot Expiration Information

Lot# BTX13 EXP: 2015/08/15

Recall Number: D-1369-2014

Reason for Recall
Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein
Initiated
10-10-2013
Reported
06-18-2014
Quantity
unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67810
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.
Pure Edge Nutrition
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.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-07-2016
Product Description About Product Description
Full technical description of the product.
Bella Vi INSANE AMP'D Dietary Supplement capsules, 60 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ

Batch or Lot Expiration Information

Lot# VINA2013 EXP: 2015/06/12

Recall Number: D-1370-2014

Reason for Recall
Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein
Initiated
10-10-2013
Reported
06-18-2014
Quantity
unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67810
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.
Pure Edge Nutrition
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.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-07-2016
Product Description About Product Description
Full technical description of the product.
Bella Vi AMP'D UP Advanced Weight Loss Dietary Supplement capsules, 60 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ

Batch or Lot Expiration Information

Lot# AU2013AB EXP: 2015/05/20 and
Lot# BVAU813 EXP: 2015/08/12

Recall Number: D-1365-2014

Reason for Recall
Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein
Initiated
10-10-2013
Reported
06-18-2014
Quantity
unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67810
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.
Pure Edge Nutrition
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.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-07-2016
Product Description About Product Description
Full technical description of the product.
Bella Vi INSANE Bee Pollen Dietary Supplement Capsules, 60 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ

Batch or Lot Expiration Information

Lot# 201303 EXP: 14/03/07