February 2018 FDA Recall Drug by Bella All Natural
D-0593-2018 - Marketed Without An Approved NDA/ANDA

This Class I drug recall was voluntarily initiated by Bella All Natural on February 14, 2018 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed in Product was distributed in California to online customers and retail stores. and the recall is currently terminated.

Recall Number: D-0593-2018

Reason for Recall
Marketed Without An Approved NDA/ANDA: This product contains undeclared sibutramine. The presence of sibutramine, a previously approved controlled substance that was withdrawn from the U.S. market in October 2010 due to safety concerns, in this tainted product renders it an unapproved drug for which safety and efficacy have not been established and therefore subject to recall.
Initiated
02-14-2018
Reported
03-14-2018
Quantity
32 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79327
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.
Bella All Natural
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed in California to online customers and retail stores.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-28-2019
Product Description About Product Description
Full technical description of the product.
Bella Capsules, 600mg, 30-count bottles, Manufactured for: Bella All Natural 304 E 11th Street, Los Angeles, CA 90015

Batch or Lot Expiration Information

Lot# : MFD:10.15.2017, Exp.10/14/2019.