FDA DrugsClass II
0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in a ...
Published: April 15, 2026Recall ID: D-0432-2026Category: drugsCountry: US
Reason for Recall / Hazard
Lack of Assurance of Sterility
Product Description & Identification
0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in a Single Dose freeflex bag, 500 mL x 20, Manufactured for: Fresenius Kabi USA, LLC ("Fresenius Kabi"), IL 60047, Unit of Use NDC: 65219-432-20, Unit of Sale NDC Number: 65219-432-85.
Additional Source Details
| Field | Value |
|---|---|
| City | Lake Zurich |
| State | IL |
| Openfda › Unii | 451W47IQ8X |
| Openfda › Route | INTRAVENOUS |
| Openfda › Rxcui › 1 | 1807634 |
| Openfda › Rxcui › 2 | 1807639 |
| Openfda › Spl id | 904e72e0-2558-4548-8ddd-8c6877c23b98 |
| Openfda › Brand name | SODIUM CHLORIDE |
| Openfda › Spl set id | 2e5fe9f4-78e5-4af4-8bf9-9680e5dc5e88 |
| Openfda › Package ndc › 1 | 65219-432-20 |
| Openfda › Package ndc › 2 | 65219-432-85 |
| Openfda › Package ndc › 3 | 65219-328-10 |
| Openfda › Package ndc › 4 | 65219-328-50 |
| Openfda › Product ndc › 1 | 65219-328 |
| Openfda › Product ndc › 2 | 65219-432 |
| Openfda › Generic name | SODIUM CHLORIDE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | SODIUM CHLORIDE |
| Openfda › Manufacturer name | Fresenius Kabi USA, LLC |
| Openfda › Application number | ANDA207310 |
| Openfda › Is original packager | true |
| Event id | 98581 |
| Address 1 | 3 Corporate Dr |
| Code info | Batch# 23DU10004, Exp Date: 04/30/2026; Batch# 23HU10006, Exp Date: 06/30/2026. |
| Postal code | 60047-8930 |
| Report date | 20260415 |
| Product type | Drugs |
| Reason for recall | Lack of Assurance of Sterility |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260311 |
| Initial firm notification | Letter |
| Center classification date | 20260403 |
Overview
- Recalling FirmFresenius Kabi USA, LLC
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide , Alaska, and Puerto Rico.