Exact FDA event identifier

Event 80814

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: August 13, 2018
Product types: Drug
Classifications: Class I
Statuses: Terminated
Recalling firm wording: Living Well Remedies, LLC

Dossier provenance

Source snapshots represented here

openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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

D-0004-2019

Recall number: D-0004-2019
Initiated: August 13, 2018
Classification: Class I
Status: Terminated
Recalling firm: Living Well Remedies, LLC
Quantity: 128 (2 fl oz spray bottles)

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0

Microbial Contamination

Potency or specification failure reason.potency_specification_failure · v1.0.0

out of specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Microbial Contamination of Non-Sterile Products: Weight Away Remedy is being recall due to out of specification microbial results.

Code information

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

Distribution pattern

United States