FDAClass IFebruary 7, 2024

VANCOmycin HCl PF recall: Superpotent

VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3208, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC…

Why was VANCOmycin HCl PF recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 2331140, Exp. Date 02/08/2024; 2331188, Exp. Date 02/15/2024; 2331261, Exp. Date 03/05/2024; 2331287, Exp. Date 03/14/2024.

Product
VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3208, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC…
Recalling firm
Denver Solutions, LLC DBA Leiters Health
Quantity
7,548 IV bags
Distribution
Nationwide within the United States
Recall date
February 7, 2024
Classification
Class I
Status
Ongoing
Agency
FDA (drug)
Open FDA enforcement record Latest recalls