D-0444-2023 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
1212 units

Product Description

Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Leiter Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-150-82

Reason for Recall

CGMP DEVIATIONS

Distribution Pattern

Nationwide within the United States including VA or other Government facilities

Code Information

Lot #: 2231017, Exp. Date 3/12/2023