FDA DrugsClass II
0.9% Sodium Chloride Injection, USP, 0.9% (900 mg per 100 mL) (9 mg per mL) 100 ...
Published: April 15, 2026Recall ID: D-0426-2026Category: drugsCountry: US
Reason for Recall / Hazard
Lack of Assurance of Sterility
Product Description & Identification
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 NDC: 65219-468-05, Unit of Sale NDC Number: 65219-468-50.
Additional Source Details
| Field | Value |
|---|---|
| City | Lake Zurich |
| State | IL |
| Openfda › Unii | 451W47IQ8X |
| Openfda › Route | INTRAVENOUS |
| Openfda › Rxcui › 1 | 1807631 |
| Openfda › Rxcui › 2 | 1807632 |
| Openfda › Rxcui › 3 | 1807633 |
| Openfda › Rxcui › 4 | 1807634 |
| Openfda › Rxcui › 5 | 1807639 |
| Openfda › Spl id | 4110390b-2806-4c92-b283-a90115f89114 |
| Openfda › Brand name | SODIUM CHLORIDE |
| Openfda › Spl set id | 037ac04d-f8f3-4bb8-993a-ac8f7683ff83 |
| Openfda › Package ndc › 1 | 65219-466-05 |
| Openfda › Package ndc › 2 | 65219-466-60 |
| Openfda › Package ndc › 3 | 65219-468-05 |
| Openfda › Package ndc › 4 | 65219-468-50 |
| Openfda › Package ndc › 5 | 65219-470-05 |
| Openfda › Package ndc › 6 | 65219-470-30 |
| Openfda › Package ndc › 7 | 65219-472-05 |
| Openfda › Package ndc › 8 | 65219-472-20 |
| Openfda › Package ndc › 9 | 65219-474-05 |
| Openfda › Package ndc › 10 | 65219-474-10 |
| Openfda › Product ndc › 1 | 65219-466 |
| Openfda › Product ndc › 2 | 65219-468 |
| Openfda › Product ndc › 3 | 65219-470 |
| Openfda › Product ndc › 4 | 65219-472 |
| Openfda › Product ndc › 5 | 65219-474 |
| 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# 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. |
| 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.