Recall events
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Event 94071
Event summary
Timeline bucket February 20, 2024
Product types Drug
Classifications Class II
Statuses Ongoing
Recalling firm wording Denver Solutions, LLC DBA Leiters Health
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
3 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 3
Moxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile injection, Intracameral Use Only, Single- Dose Vial, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-096-42
D-0361-2024
Recall number D-0361-2024
Initiated February 20, 2024
Classification Class II
Status Ongoing
Quantity 40,090 vials
App-derived interpretation
Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0
Particulate Matter
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Code information Lot #:2331147, Exp:6-Mar-24; 2331180, Exp: 21-Mar-24; 2331256, Exp: 2-Apr-24; 2331279, Exp: 3-Apr-24; 2331283, Exp: 7-Apr-24; 2331345, Exp: 20-Apr-24; 2331422, Exp: 27-Apr-24; 2331563, Exp: 29-May-24.
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[5166]
FDA event record
· Exact recall-number query on openFDA
drug · product 2 of 3
Moxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-097-42
D-0362-2024
Recall number D-0362-2024
Initiated February 20, 2024
Classification Class II
Status Ongoing
Quantity 10,020 vials
App-derived interpretation
Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0
Particulate Matter
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Code information Lot #:2331123, Exp:28-Feb-24; 2331298, Exp: 24-Mar-24.
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[5152]
FDA event record
· Exact recall-number query on openFDA
drug · product 3 of 3
Lidocaine HCL 1% (10mg/mL), PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Single- Dose Vial, RX Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-090-42
D-0363-2024
Recall number D-0363-2024
Initiated February 20, 2024
Classification Class II
Status Ongoing
Quantity 40,890 vials
App-derived interpretation
Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0
Particulate Matter
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Code information Lot #:2331104, Exp:9-Mar-24; 2331137, Exp: 3-Mar-24; 2331196, Exp: 11-Mar-24; 2331264, Exp: 6-Apr-24; 2331282, Exp: 18-Apr-24; 2331464, Exp: 8-May-24; 2331481, Exp: 16-May-24; 2331500, Exp: 20-May-24.
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[930]
FDA event record
· Exact recall-number query on openFDA
