FDA DrugsClass II
0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 25...
Published: April 15, 2026Recall ID: D-0424-2026Category: drugsCountry: US
Reason for Recall / Hazard
Lack of Assurance of Sterility
Product Description & Identification
0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 63323-626-03, Unit of Sale NDC Number: 63323-626-25 (30 bags in 1 case).
Additional Source Details
| Field | Value |
|---|---|
| City | Lake Zurich |
| State | IL |
| Openfda › Unii | 451W47IQ8X |
| Openfda › Route | INTRAVENOUS |
| Openfda › Rxcui › 1 | 1807548 |
| Openfda › Rxcui › 2 | 1807549 |
| Openfda › Rxcui › 3 | 1807550 |
| Openfda › Rxcui › 4 | 1807551 |
| Openfda › Rxcui › 5 | 1807552 |
| Openfda › Spl id | 713303dd-2658-4037-8583-a12a38eb367b |
| Openfda › Brand name | SODIUM CHLORIDE |
| Openfda › Spl set id | 83994d0c-8484-4505-abb5-8a384ed12288 |
| Openfda › Package ndc › 1 | 63323-626-01 |
| Openfda › Package ndc › 2 | 63323-626-50 |
| Openfda › Package ndc › 3 | 63323-626-02 |
| Openfda › Package ndc › 4 | 63323-626-00 |
| Openfda › Package ndc › 5 | 63323-626-03 |
| Openfda › Package ndc › 6 | 63323-626-25 |
| Openfda › Package ndc › 7 | 63323-626-04 |
| Openfda › Package ndc › 8 | 63323-626-55 |
| Openfda › Package ndc › 9 | 63323-626-05 |
| Openfda › Package ndc › 10 | 63323-626-10 |
| Openfda › Product ndc | 63323-626 |
| 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 | ANDA208122 |
| Openfda › Is original packager | true |
| Event id | 98581 |
| Address 1 | 3 Corporate Dr |
| Code info | Batch # 6402413, Exp Date: 02/29/2028 |
| 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.