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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85239

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

Open FDA event record

Event summary

Timeline bucket
March 25, 2020
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Akorn 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 Injection, USP, 100 mcg/2 mL (50 mcg/mL), 10 Ampules per carton, (2 mL each), Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-030-02

D-1258-2020
Recall number
D-1258-2020
Initiated
March 25, 2020
Classification
Class III
Status
Terminated
Recalling firm
Akorn Inc
Quantity
15,170 ampules

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Out-of-Specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed impurities/degradation specification: Out-of-Specification result for total impurity at 4.1% (Limit: NMT 3.0%) during retained sample testing.

Code information

Lot 081887A, EXP 08/2021

Distribution pattern

Distributed Nationwide in the USA