Fresenius Kabi 5% Dextrose Recall, Sterility Issue

Fresenius Kabi USA, LLC

Drug Recalls (Class II)

← All Drug Recalls (Class II) Class II D-0437-2026 · 20260415 · Ongoing · Voluntary: Firm initiated

Product

5% Dextrose Injection, USP 12.5 g per 250 mL (50 mg per mL) 250 mL in a 250 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-458-05, Unit of Sale NDC Number: 6521...

Reason for Recall

Lack of Assurance of Sterility

Affected Lot Numbers / Codes

Batch# 6402165, Exp Date: 05/30/2028.

Firm Notification Method

Letter

Distribution

US Nationwide , Alaska, and Puerto Rico.

Initiated

20260311

FDA Classified

20260403

Product Registration

Brand: DEXTROSE

Generic: DEXTROSE MONOHYDRATE

Manufacturer: FRESENIUS KABI USA, LLC

Application: ANDA207449

NDC: 65219-456, 65219-464, 65219-458

Drug Label Context (from openFDA)

The following is from the manufacturer's FDA-approved drug label, not recall-specific. Provided for context.

Indications & Usage

INDICATIONS AND USAGE: Intravenous solutions containing dextrose are indicated for parenteral replenishment of fluid and minimal carbohydrate calories as required by the clinical condition of the patient.

Dosage & Administration

DOSAGE AND ADMINISTRATION: The dose is dependent upon the age, weight and clinical condition of the patient. As reported in the literature, the dosage and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low birth weight infants, because of the increased risk of hyperglycemia/hypoglycemia.

Contraindications

CONTRAINDICATIONS: 5% Dextrose Injection, USP without electrolytes should not be administered simultaneously with blood through the same infusion set because of the possibility that pseudoagglutination of red cells may occur.

Warnings

WARNINGS: Excessive administration of potassium-free solutions may result in significant hypokalemia. The intravenous administration of these solutions can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of administered parenteral solutions. The risk of solute overload causing congested states with periph...

Adverse Reactions

ADVERSE REACTIONS: Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary. To report SUSPECTED ADVE...

Drug Interactions

Drug Interactions Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit (see PRECAUTIONS ).

How Supplied

HOW SUPPLIED: 5% Dextrose Injection, USP is supplied in single dose flexible plastic containers as follows: Product Code Unit of Sale Strength Each 416460 NDC 65219-456-60 Package of 60 2.5 grams per 50 mL (50 mg per mL) NDC 65219-456-05 50 mL fill in a 100 mL free flex® bag 416450 NDC 65219-464-50 Package of 50 5 grams per 100 mL (50 mg per mL) NDC 65219-464-05 One 100 mL free flex® bag 416430...

Sources: openFDA · Raw JSON