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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84244

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

Open FDA event record

Event summary

Timeline bucket
November 12, 2019
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
AuroMedics Pharma 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

Fluphenazine Decanoate Injection USP 125mg/5mL, (5 mL Multiple Dose Vial), Rx only, For IM or SC Use, Mfd in India for: AuroMedics Pharma, LLC, E. Windsor, NJ

D-0609-2020
Recall number
D-0609-2020
Initiated
November 12, 2019
Classification
Class II
Status
Terminated
Recalling firm
AuroMedics Pharma LLC
Quantity
59,500 vials

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Discoloration; Hazy solution found in one vial instead of a clear solution.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Discoloration; Hazy solution found in one vial instead of a clear solution.

Code information

Lot CFD190004, exp. date August 2020

Distribution pattern

Product was distributed to major wholesalers/distributors who may have further distribute the product throughout the United States.