Exact FDA event identifier

Event 70465

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

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Event summary

Timeline bucket: January 26, 2015
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: AnazaoHealth Corporation

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

Compounded Plaquex, intravenous injection, 50 ML vial. Each ml contains: Phosphatidyl Choline 50 mg, Sodium Deoxycholate 25 mg, Benzyl Alcohol 0.9%, Ethanol (95%) 2.4 mg di Alpha Tocopheryl Acetate 0.2 mg in Sterile Water for injection.

D0384-2015

Recall number: D0384-2015
Initiated: January 26, 2015
Classification: Class II
Status: Terminated
Recalling firm: AnazaoHealth Corporation
Quantity: 51 vials

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

Good Manufacturing Practices Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.

Code information

Lot #: 112614-1MC-82186 Exp 5/26/2015; 112614-1MC-82187 Exp 5/26/2015; 112614-1MC-82188 Exp 05/26/205 ;112614-1MC-82189 Exp 5/26/2015

Distribution pattern

Nationwide