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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84618

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

Open FDA event record

Event summary

Timeline bucket
January 10, 2019
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
McGuff Compounding Pharmacy Services, Inc.

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

Lipoic Acid Injection (aka Alpha Lipoic Acid or Thioctic Acid), 1,200 mg/30 mL (40 mg/mL) Sterile 30 mL Multiple Dose Vial, Rx Only, McGuff Compounding Pharmacy Services, Inc., Santa Ana, CA 92704

D-0802-2020
Recall number
D-0802-2020
Initiated
January 10, 2019
Classification
Class II
Status
Terminated
Quantity
146 30 ml vials were dispensed

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate Matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Presence of Particulate Matter: filmy/cloudy particulate observed in vial.

Code information

Lot #: 18M0991, Preparation #: 390-2678, Beyond Usage Date: 06/15/2019

Distribution pattern

Distributed Nationwide in the US