D-0442-2023 Class II Terminated

Recalled by Denver Solutions, LLC DBA Leiters Health — Englewood, CO

Recall Details

Product Type
Drugs
Report Date
March 15, 2023
Initiation Date
February 21, 2023
Termination Date
January 11, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
13,445 units

Product 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

Reason for Recall

CGMP DEVIATIONS

Distribution Pattern

Nationwide within the United States including VA or other Government facilities

Code Information

Lot #: 2230960, Exp date 3/12/2023; 2231080, Exp date 4/9/2023.