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FDARecalled Apr 15, 2026 · #D-0433-2026

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, Distributed by: Fresenius Medica...

Hazard

Class II — temporary health risk

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Description

Lack of Assurance of Sterility Classification: Class II Distribution: US Nationwide , Alaska, and Puerto Rico.

Product details

Product
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, Distributed by: Fresenius Medical Care RTG, LLC, Manufactured by: Fresenius Kabi, Unit of Use NDC: 65219-282-01, Unit of Sale NDC Number: 65219-282-10.
Type
Drugs
Manufacturer
Fresenius Kabi USA, LLC
Model numbers
UPCs