Drug Enforcement D-0281-2024

Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.

Status

Ongoing

Classification

Class I

Report Date

February 7, 2024

Termination Date

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Product Information

Product description
VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3206, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-028-68.
Product quantity
10,152 IV bags
Reason for recall
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Recall initiation reason
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Initial firm notification
E-Mail
Distribution pattern
Nationwide within the United States

Location & Firm

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

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0281-2024
Event ID
93710
Recall initiation date
December 28, 2023
Center classification date
January 29, 2024
Code info
Lot #: 2331184, Exp. Date 02/13/2024; 2331185, Exp. Date 02/10/2024; 2331189, Exp. Date 02/20/2024; 2331191, Exp. Date 02/24/2024; 2331258,Exp. Date 03/03/2024; 2331317, Exp. Date 03/15/2024.
More code info
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