Fresenius Kabi USA, LLC: 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL in a Single Dose freeflex bag, Rx only, BD Beckton, Dickson and
Read the official notice at FDA (drug) →
The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- Fresenius Kabi USA, LLC
- Product
- 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL in a Single Dose freeflex bag, Rx only, BD Beckton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by: Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-03.
- Reason / hazard
- Lack of Assurance of Sterility
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide , Alaska, and Puerto Rico.
- Recall initiated
- 2026-03-11
- Code info
- Batch# 6402153, Exp Date: 11/30/2026; Batch# 6402297, 6402298, Exp Date: 01/31/2027; Batch# 6402377, 6402378, 6402379, Exp Date: 02/28/2027; Batch # 6402429, 6402430, 6402431, 6402432, 6402433, Exp Date: 03/31/2027; Batch# 6402434, Exp Date: 04/30/2027; Batch# 6402512, Exp Date: 05/2027; Batch# 6402574, 6402576, Exp Date: 06/30/2027.
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Lake Zurich
- State
- IL
- Country
- United States
- Event id
- 98581
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