Recall archive / FDA drug enforcement

Phenylephrine HCl 0.5 mg per 5 mL (100 mcg/mL), 5 mL Syringe, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112,... — FDA record D-0442-2023

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Feb 21, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: 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
Reason: CGMP DEVIATIONS
Classification: Class II
Recalling firm: Denver Solutions, LLC DBA Leiters Health
Quantity: 13,445 units
Agency-reported status: Terminated
Source record identifier: D-0442-2023

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	Lot #: 2230960, Exp date 3/12/2023; 2231080, Exp date 4/9/2023.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Nationwide within the United States including VA or other Government facilities

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Mar 15, 2023
Recall initiation date: Feb 21, 2023
Center classification date: Mar 7, 2023
Termination date: Jan 11, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.