FDA recall D-0442-2023
Denver Solutions, LLC DBA Leiters Health · Class II · drug
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 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-0442-2023