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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91229

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

Open FDA event record

Event summary

Timeline bucket
November 29, 2022
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
OurPharma 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

FentaNYL Citrate 2.5 mg/50 mL (50mcg/ml) Injection Solution, Preservative Free, Single Use 50 ml Cassette, Rx Only, Repackaged by OurPharma, LLC. 2512 S. City Lake Rd. Fayetteville, AR 72701, 1-833-290-2654, NDC 73013-001-01

D-0078-2023
Recall number
D-0078-2023
Initiated
November 29, 2022
Classification
Class II
Status
Terminated
Recalling firm
OurPharma LLC
Quantity
691 cassettes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Underfilled units.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Underfilled units.

Code information

Lots: 100122060007 Exp. 12/17/2022; 100122060008 Exp. 12/18/2022; 100122070002 Exp. 01/09/2023.

Distribution pattern

MO