Exact FDA event identifier

Event 86802

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

Event summary

Timeline bucket: November 20, 2020
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

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

Fentanyl, 250 mcg/ 5mL, Injection for IV or IM use, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct., Little Rock, AR 72205

D-0147-2021

Recall number: D-0147-2021
Initiated: November 20, 2020
Classification: Class III
Status: Terminated
Recalling firm: SCA Pharmaceuticals
Quantity: 4,843 syringes

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Subpotency

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotency: Out-of-specification stability test result for low potency was obtained.

Code information

Lot #: 1220021578, Exp 12/2/2020; 1220021732, Exp 12/9/2020; 1220022385, Exp 12/29/2020; 1220022582, Exp 1/6/2021

Distribution pattern

Product was distributed to three hospitals in MO & LA.