FDA DrugsClass II
0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL), 1,000 mL in...
Published: April 15, 2026Recall ID: D-0434-2026Category: 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), 1,000 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Becton Drive, Franklin Lakes, NJ 07417, Distributed by BD, Manufactured by Fresenius Kabi, Unit of Sale NDC Number: 17271-701-07.
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 | 31344de2-e115-440a-a913-ff63da5f17d8 |
| Openfda › Brand name | SODIUM CHLORIDE |
| Openfda › Spl set id | ebc8b008-a8b3-4c41-89e4-b413f7aab89f |
| Openfda › Package ndc › 1 | 17271-701-02 |
| Openfda › Package ndc › 2 | 17271-701-03 |
| Openfda › Package ndc › 3 | 17271-701-05 |
| Openfda › Package ndc › 4 | 17271-701-06 |
| Openfda › Package ndc › 5 | 17271-701-07 |
| Openfda › Product ndc | 17271-701 |
| Openfda › Generic name | SODIUM CHLORIDE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | SODIUM CHLORIDE |
| Openfda › Manufacturer name | Becton Dickinson and Company |
| Openfda › Application number | ANDA207310 |
| Openfda › Is original packager | true |
| Event id | 98581 |
| Address 1 | 3 Corporate Dr |
| Code info | Batch# 24EU10010, Exp Date: 05/31/2027. |
| 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.