Fresenius Kabi USA Recalls 0.9% Sodium Chloride Injection Due to Lack of Sterility Assurance

Fresenius Kabi USA, LLC

Drug Recalls (Class II)

← All Drug Recalls (Class II) Class II D-0426-2026 · 20260415 · Ongoing · Voluntary: Firm initiated

Product

0.9% Sodium Chloride Injection, USP, 0.9% (900 mg per 100 mL) (9 mg per mL) 100 mL in a 100 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 600047, Unit of Use...

Reason for Recall

Lack of Assurance of Sterility

Affected Lot Numbers / Codes

Batch# 6402299, 6402300, 6402301, 6402302, 6402303, Exp Date: 01/31/2027; Batch# 6402305, 6402398, Exp Date: 02/28/2027; Batch# 6402467, Exp Date: 04/30/2027; Batch# 6402577, 6402578, Exp Date: 06/30/2027.

Firm Notification Method

Letter

Distribution

US Nationwide , Alaska, and Puerto Rico.

Initiated

20260311

FDA Classified

20260403

Product Registration

Brand: SODIUM CHLORIDE

Manufacturer: Fresenius Kabi USA, LLC

Application: ANDA207310

NDC: 65219-466, 65219-468, 65219-470

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 sodium chloride are indicated for parenteral replenishment of fluid and sodium chloride 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. 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 ).

Contraindications

CONTRAINDICATIONS None known.

Warnings

WARNINGS Sodium Chloride Injection, USP should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention. The intravenous administration of Sodium Chloride Injection, USP can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutive states is inversely proportiona...

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 ADVER...

Drug Interactions

DRUG INTERACTIONS Caution must be exercised in the administration of Sodium Chloride Injection, USP to patients receiving corticosteroids or corticotropin. Carcinogenesis, Mutagenesis, Impairment of Fertility Studies have not been performed with Sodium Chloride Injection, USP to evaluate the potential for carcinogenesis, mutagenesis or impairment of fertility. Pregnancy: Teratogenic Effects Animal reproduction studies have not been conducted with Sodium Chloride Injection, USP. It is also not...

How Supplied

HOW SUPPLIED 0.9% Sodium Chloride Injection, USP is supplied in single-dose flexible plastic containers as follows: Product Code Unit of Sale Strength Each 416660 NDC 65219-466-60 Package of 60 0.9% (9 mg/mL) NDC 65219-466-05 50 mL in a 100 mL free flex ® bag 416650 NDC 65219-468-50 Package of 50 0.9% (9 mg/mL) NDC 65219-468-05 100 mL in a 100 mL free flex ® bag 416630 NDC 65219-470-30 Package ...

Sources: openFDA · Raw JSON