December 2017 FDA Recall Drug by Botanicalnow
D-0471-2018 - Marketed without an approved NDA/ANDA

This Class I drug recall was voluntarily initiated by Botanicalnow on December 7, 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-0471-2018

Reason for Recall
Marketed without an approved NDA/ANDA: FDA analysis found the product to contain undeclared sibutramine.
Initiated
12-07-2017
Reported
01-31-2018
Quantity
5 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78720
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.
BotanicalNow
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-25-2020
Product Description About Product Description
Full technical description of the product.
BodySlim Herbal Advanced technology & Strong formula capsules, 400 mg, 30-count bottle, Barcode: 9567153432481

Batch or Lot Expiration Information

Lot# MFD: 05.06.2016 EXP: 05.05.2018