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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81011

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

Open FDA event record

Event summary

Timeline bucket
August 31, 2018
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
BioLyte Laboratories, 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

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

NeoRelief for Muscle Cramping & Restlessness Homeopathic Topical Gel, packaged in a) 4 ml sample packs and b) Net Wt. 2.0 oz (56.7g) bottles, BioLyte Laboratories - Grand Rapids, MI 49534, NDC 58368-002-02

D-0002-2019
Recall number
D-0002-2019
Initiated
August 31, 2018
Classification
Class II
Status
Terminated
Recalling firm
BioLyte Laboratories, LLC
Quantity
a) 500 sample packs; b) 672 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: finished product produced with active ingredients recalled by the manufacturer, King Bio Inc., due to water contamination issues that could potentially affect the quality of this product.

Code information

Lot #: a) 1146, Exp 3/29/20; b) 1138, 1139, Exp 1/31/20; and 1160, Exp 10/10/19

Distribution pattern

Nationwide in the USA