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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80354

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

Open FDA event record

Event summary

Timeline bucket
June 20, 2018
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Advanced Pharma 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

fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL, 10 mcg per mL prefilled syringe, Rx only, Advanced Pharma an FDA Regulated 503B Outsourcing Facility 9265 Kirby Dr., Houston, TX 77054, NDC 15082-210-72.

D-0889-2018
Recall number
D-0889-2018
Initiated
June 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
Advanced Pharma Inc.
Quantity
100 syringes

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug: final drug concentration is subpotent as compared to the concentration indicated on the label.

Code information

Lot #: 6/12/18 0432 149-21072S, BUD 9/10/18

Distribution pattern

Distributed to one medical center in Fort Worth, TX.