Recall events
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Event 96607
Event summary
Timeline bucket March 31, 2025
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
5 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 5
Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC 71449-104-11
D-0370-2025
Recall number D-0370-2025
Initiated March 31, 2025
Classification Class II
Status Ongoing
Quantity 170 syringes
App-derived interpretation
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: Leaking/damaged syringes.
Code information Lot #: 2431015B, Exp. 4/10/2025.
Distribution pattern Nationwide in the U.S.A
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[621]
FDA event record
· Exact recall-number query on openFDA
drug · product 2 of 5
dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg (base) per 5mL, (4 mcg (base) per mL), 5mL Single Dose syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112, NDC: 71449-131-11.
D-0371-2025
Recall number D-0371-2025
Initiated March 31, 2025
Classification Class II
Status Ongoing
Quantity 23,610 syringes
App-derived interpretation
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: Leaking/damaged syringes.
Code information Lot #: 2431276A, Exp.: 4/20/2025
Distribution pattern Nationwide in the U.S.A
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[620]
FDA event record
· Exact recall-number query on openFDA
drug · product 3 of 5
PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL Single Dose Syringe, Rx Only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-001-11,
D-0372-2025
Recall number D-0372-2025
Initiated March 31, 2025
Classification Class II
Status Ongoing
Quantity 7,290 syringes
App-derived interpretation
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: Leaking/damaged syringes.
Code information Lot #: 2431349A, Exp.: 6/16/2025
Distribution pattern Nationwide in the U.S.A
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[686]
FDA event record
· Exact recall-number query on openFDA
drug · product 4 of 5
Ketamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112.NDC: 71449-068-11
D-0373-2025
Recall number D-0373-2025
Initiated March 31, 2025
Classification Class II
Status Ongoing
Quantity 49,830 syringes
App-derived interpretation
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: Leaking/damaged syringes.
Code information Lot #:2530019, Exp.: 7/10/2025; 2530053, Exp.: 7/19/2025.
Distribution pattern Nationwide in the U.S.A
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[714]
FDA event record
· Exact recall-number query on openFDA
drug · product 5 of 5
Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-004-11
D-0374-2025
Recall number D-0374-2025
Initiated March 31, 2025
Classification Class II
Status Ongoing
Quantity 16,655 syringes
App-derived interpretation
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: Leaking/damaged syringes.
Code information Lot #:2530023, Exp.: 7/12/2025
Distribution pattern Nationwide in the U.S.A
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[628]
FDA event record
· Exact recall-number query on openFDA
