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FDAMarch 5, 2020drug

Sodium Chloride 0.9% Injection, USP, 1000 mL bags, Rx only, Manufactured by: Fresenius Medical Care North America, Waltham, MA 02451

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

CGMP Deviation: Chemical indicators were not positioned properly during sterilization process.

What to do

FDA enforcement status: Terminated

Brands named

fresenius medical carefreseniusfresenius medical

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Sodium Chloride 0.9% Injection, USP, 1000 mL bags, Rx only, Manufactured by: Fresenius Medical Care North America, Waltham, MA 02451 — Recall Details · AllClear