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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91774

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

Open FDA event record

Event summary

Timeline bucket
February 24, 2023
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
SCA Pharmaceuticals

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 1,500 mcg/30 mL syringe, Injection for Intravenous Use, Concentration = 50 mcg/mL, Preservative Free, Rx Only, Single Dose Container, SCA Pharmaceuticals, Windsor CT 06095, NDC# 70004-0200-16.

D-0363-2023
Recall number
D-0363-2023
Initiated
February 24, 2023
Classification
Class III
Status
Terminated
Recalling firm
SCA Pharmaceuticals
Quantity
2125 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

Code information

Lot # 1222043351, exp. date 03/29/2023 1222043387, exp. date 04/05/2023 1222043352, exp. date 04/05/2023 1222043463, exp. date 04/06/2023 1223043922, exp. date 05/04/2023

Distribution pattern

Nationwide in the US.