Product Safety Recalls

Product Recall Tracker

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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0442-2023
Event ID91762
DistributionNationwide within the United States including VA or other Government facilities
Quantity13,445 units
Recall ReasonCGMP DEVIATIONS
Drug ClassificationClass II
Drug Code Info20230315
Recall Initiation Date20230221
Report Date20230315
Classification Date20230307
Address13796 Compark Blvd
Englewood, CO 80112-7145
United States
Recalling FirmDenver Solutions, LLC DBA Leiters Health
Initial Notification E-Mail
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