Drug Enforcement D-0444-2023

CGMP DEVIATIONS

Status

Terminated

Classification

Class II

Report Date

March 15, 2023

Termination Date

January 11, 2024

Product Information

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
Product quantity
1212 units
Reason for recall
CGMP DEVIATIONS
Recall initiation reason
—
Initial firm notification
E-Mail
Distribution pattern
Nationwide within the United States including VA or other Government facilities

Location & Firm

Recalling firm
Denver Solutions, LLC DBA Leiters Health
Address
13796 Compark Blvd

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0444-2023
Event ID
91762
Recall initiation date
February 21, 2023
Center classification date
March 7, 2023
Code info
Lot #: 2231017, Exp. Date 3/12/2023
More code info
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