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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91762

4 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
February 21, 2023
Product types
Drug
Classifications
Class II
Statuses
Terminated
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

Complete imported group

Every recalled product in this event

4 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 4

Phenylephrine HCl 0.5 mg per 5 mL (100 mcg/mL), 5 mL Syringe, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-11

D-0442-2023
Recall number
D-0442-2023
Initiated
February 21, 2023
Classification
Class II
Status
Terminated
Quantity
13,445 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP DEVIATIONS

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP DEVIATIONS

Code information

Lot #: 2230960, Exp date 3/12/2023; 2231080, Exp date 4/9/2023.

Distribution pattern

Nationwide within the United States including VA or other Government facilities

drug · product 2 of 4

Phenylephrine HCl 1mg per 10mL (100 mcg/mL) 10 mL syringes, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-15

D-0443-2023
Recall number
D-0443-2023
Initiated
February 21, 2023
Classification
Class II
Status
Terminated
Quantity
325,300 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP DEVIATIONS

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP DEVIATIONS

Code information

Lot #: 2230895, Exp. Date 3/5/2023; 2230911, Exp. Date 3/11/2023; 2230913, Exp. Date 3/18/2023; 2230994, Exp. Date 3/27/2023; 2231006, Exp. Date 4/1/2023; 2231109, Exp. Date 4/19/2023; 2231126, Exp. Date 5/6/2023; 2231134, Exp. Date 5/10/2023; 2231140, Exp. Date 5/14/2023; 2231142, Exp. Date 5/20/2023; 2231156, Exp. Date 5/29/2023; 2231273, Exp. Date 6/3/2023; 2231285, Exp. Date 6/10/2023; 2231299, Exp. Date 6/17/2023; 2231331, Exp. Date 6/26/2023; 2330014, Exp. Date 7/9/2023; 2330025, Exp. Date 7/15/2023

Distribution pattern

Nationwide within the United States including VA or other Government facilities

drug · product 3 of 4

Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Leiter Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-150-82

D-0444-2023
Recall number
D-0444-2023
Initiated
February 21, 2023
Classification
Class II
Status
Terminated
Quantity
1212 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP DEVIATIONS

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP DEVIATIONS

Code information

Lot #: 2231017, Exp. Date 3/12/2023

Distribution pattern

Nationwide within the United States including VA or other Government facilities

drug · product 4 of 4

Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-148-94

D-0445-2023
Recall number
D-0445-2023
Initiated
February 21, 2023
Classification
Class II
Status
Terminated
Quantity
8,136 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP DEVIATIONS

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP DEVIATIONS

Code information

Lot #: 2231026, Exp. Date 2/23/2023; 2231051, Exp. Date 3/11/2023; 2231156, Exp. Date 5/29/2023; 2231163, Exp. Date 3/26/2023; 223130, Exp. Date 4 5/7/2023; 2231308, Exp. Date 5/11/2023

Distribution pattern

Nationwide within the United States including VA or other Government facilities