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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86834

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

Open FDA event record

Event summary

Timeline bucket
November 18, 2020
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Fusion Health and Vitality 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

Immune Boost with natural strawberry flavor, 8,000 IU, Supports a Healthy and Balanced Immune System, 60 mL bottle, Manufactured by: Fusion Health and Vitality, LLC. 1360 Union Hill Road, Suite 11B Alpharetta, GA 30004.

D-0107-2021
Recall number
D-0107-2021
Initiated
November 18, 2020
Classification
Class II
Status
Terminated
Quantity
5000 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Marketed without an Approved NDA/ANDA: Product marketed with drug claims.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Marketed without an Approved NDA/ANDA: Product marketed with drug claims.

Code information

Lot #s: 200407, 200413, 200420, 200602, 200608.

Distribution pattern

Nationwide in the U.S.

Field note

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