0.9% Sodium Chloride Injection recall

Lack of Assurance of Sterility

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.

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Company

Fresenius Kabi USA, LLC, Lake Zurich, IL

Date

Wednesday, April 15

Severity

Class II
the product could cause temporary or reversible health problems.

Where sold

Nationwide
US Nationwide , Alaska, and Puerto Rico.

Status

Ongoing

Recall number

D-0433-2026

Source

U.S. Food and Drug Administration