Fresenius Kabi USA, LLC: 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 mL in a Single Dose freeflex bag, 1,000 mLx10, Fresenius Medical Care, Waltham, MA 02451, Distribute

Hazard

Lack of Assurance of Sterility

Details from the source

Reason for recall: Lack of Assurance of Sterility Distribution: US Nationwide , Alaska, and Puerto Rico. Lot/code info: Batch# 23SU10001, Exp Date: 12/31/2026; Batch# 24AU10003, 24AU10004, 24AU10005, 24AU10008, Exp Date: 01/31/2027; Batch # 24EU10001, 24EU10002, Exp Date: 05/31/2027; Batch# 24PU10002, Exp Date: 11/30/2027; Batch# 25BU10003, Exp Date: 02/29/2028; Batch# 25EU10005, Exp Date: 05/31/2028.

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.