The Recall Registry
Recall data checked 5 hours ago

Home Prescription medicine Denver Solutions, LLC DBA Leiters Health —…

Food & drug recall · FDADecember 28, 2023Highest risk

Denver Solutions, LLC DBA Leiters Health — 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 71449-029-68.

Do not stop taking this without speaking to your pharmacist or doctor.

What’s wrong

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

The Recall Registry rates this highest riskFDA Class I: reasonable probability of serious harm or death.

What to do

Check the lot numbers below against what you have. Do not stop taking a prescription medicine because of a recall without speaking to your pharmacist or doctor first — for many medicines stopping is more harmful than continuing, and they can tell you whether yours is affected and what to do about it.

Who to contact: Recalling firm: Denver Solutions, LLC DBA Leiters Health

The 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 71449-029-68.

Details

Units affected
7,548 IV bags
Recall date
December 28, 2023
Brand
Denver Solutions, LLC DBA Leiters Health
Model, lot or SKU numbers
Lot #: 2331140, Exp. Date 02/08/20242331188, Exp. Date 02/15/20242331261, Exp. Date 03/05/20242331287, Exp. Date 03/14/2024.
Where it was distributed

Nationwide within the United States

The official notice

This recall was issued by the U.S. Food and Drug Administration. The Recall Registry summarises it — always confirm the details at the source.

Their exact wording: Denver Solutions, LLC DBA Leiters Health — 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 71449-029-68.

Read it on FDA

Worried about the other things in your house? You can write down what you have and be told if one is recalled — or, if you sell second-hand, check your whole stock at once.

Filed under: Prescription medicine

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