August 2018 FDA Recall Drug by Living Well Remedies, Llc
D-0004-2019 - Microbial Contamination of Non-Sterile Products

This Class I drug recall was voluntarily initiated by Living Well Remedies, Llc on August 13, 2018 for the product Drug. The FDA reported the reason for recall as microbial contamination of non-sterile products. The product was distributed in United States and the recall is currently terminated.

Recall Number: D-0004-2019

Reason for Recall
Microbial Contamination of Non-Sterile Products: Weight Away Remedy is being recall due to out of specification microbial results.
Initiated
08-13-2018
Reported
09-05-2018
Quantity
128 (2 fl oz spray bottles)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80814
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.
Living Well Remedies, 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-18-2025
Product Description About Product Description
Full technical description of the product.
Living Well Remedies Weight Away Remedy, 2 fl oz (59 mL) Distributed by Living Well Remedies, LLC P.O. Box 704, Franklin Lakes, NJ 07417 www.LivingWellRemedies.com. Made in the USA

Batch or Lot Expiration Information

Lot# : 111417LWL614, Exp 11/14/19