Exact FDA event identifier

Event 91911

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

Event summary

Timeline bucket: March 16, 2023
Product types: Drug
Classifications: Class III
Statuses: Ongoing
Recalling firm wording: Focus Health Group 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

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

Epinephrine Professional EMS, Epinephrine Convenience Kit, Epinephrine 1 mg/mL, Rx Only, Focus Health Group, Manufactured for: Focus Health Group, 5802 Kingston Pike, Knoxville, TN 37919. Incorrect NDC (kit): 24357-011-13

D-0535-2023

Recall number: D-0535-2023
Initiated: March 16, 2023
Classification: Class III
Status: Ongoing
Recalling firm: Focus Health Group Inc
Quantity: 246 kits

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling; Incorrect

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling; Incorrect NDC number on outer carton of product.

Code information

Lot numbers: 57943EMS, exp 5/31/2023; 56276EMS, exp 4/30/2024

Distribution pattern

Nationwide in the USA