March 2017 FDA Recall Drug by Envy Me
D-0867-2017 - Marketed without an approved NDA/ANDA

This Class I drug recall was voluntarily initiated by Envy Me on March 28, 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.

Recall Number: D-0867-2017

Reason for Recall
Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine.
Initiated
03-28-2017
Reported
05-31-2017
Quantity
unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76858
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.
Envy Me
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.
Other
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product sold nationwide through internet sales. No foreign consignees were reported.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-03-2021
Product Description About Product Description
Full technical description of the product.
LaBri's Body Health Atomic, 60 capsules

Batch or Lot Expiration Information

Lot# All lot codes, manufacturing codes and expiration dates.