Recall D-0442-2023
Description: 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
Recall D-0442-2023 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0442-2023 |
Event ID | 91762 |
Distribution | Nationwide within the United States including VA or other Government facilities |
Quantity | 13,445 units |
Recall Reason | CGMP DEVIATIONS |
Drug Classification | Class II |
Drug Code Info | 20230315 |
Recall Initiation Date | 20230221 |
Report Date | 20230315 |
Classification Date | 20230307 |
Address | 13796 Compark Blvd Englewood, CO 80112-7145 United States |
Recalling Firm | Denver Solutions, LLC DBA Leiters Health |
Initial Notification | |
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