Multi-event November 2014 FDA Recall Drug by Refa Enterprises, Llc

This Multi-event Class I drug recall was voluntarily initiated by Refa Enterprises, Llc on November 3, 2014 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-0993-2015 TERMINATED D-0994-2015 TERMINATED

Recall Number: D-0993-2015

Reason for Recall
Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain sibutramine and phenolphthalein
Initiated
11-03-2014
Reported
05-13-2015
Quantity
92 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
69729
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.
REFA Enterprises, 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.
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.
11-04-2015
Product Description About Product Description
Full technical description of the product.
Forever Beautiful INFINITY, capsules, 300mg in 60-count bottles, 900 Commonwealth Place, Ste 104, Virginia Beach, VA

Batch or Lot Expiration Information

Lot# UPC CODE: 633090804649 Exp unknown

Recall Number: D-0994-2015

Reason for Recall
Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain sibutramine and phenolphthalein
Initiated
11-03-2014
Reported
05-13-2015
Quantity
92 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
69729
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.
REFA Enterprises, 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.
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.
11-04-2015
Product Description About Product Description
Full technical description of the product.
Forever Beautiful BEE POLLEN, capsules, 250mg in 60-count bottles, 900 Commonwealth Place, Ste 104, Virginia Beach, VA

Batch or Lot Expiration Information

Lot# UPC CODE: 633090804632, Exp unknown