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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91674

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

Open FDA event record

Event summary

Timeline bucket
February 08, 2023
Product types
Drug
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Apollo Care

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 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (1mg/mL) added to 250mL 0.9% Sodium Chloride, For Epidural Use Only, Rx only, 3801 Mojave Ct. Suite 101, Columbia, MO 65202, NDC 71170-950-25

D-0487-2023
Recall number
D-0487-2023
Initiated
February 08, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Apollo Care
Quantity
215 bags

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
microbial growth
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of assurance of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of assurance of sterility: Suspected microbial growth present on external label packaging.

Code information

Lot #: AC-016581

Distribution pattern

MO