FDA recall D-0445-2023

Denver Solutions, LLC DBA Leiters Health · Class II · drug

Product

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

Reason for recall

CGMP DEVIATIONS

Distribution

Nationwide within the United States including VA or other Government facilities

Key facts

Status: Terminated
Initiation date: 2023-02-21
Report date: 2023-03-15
Termination date: 2024-01-11
Voluntary/Mandated: Voluntary: Firm initiated
Location: Englewood, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0445-2023