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FDASeptember 12, 2019drug

Sodium Bicarbonate 8.4%, 4,200 mg / 50 mL 50 mEq / 50 mL (84 mg/mL) (1 mEq/mL), 50 mL Fill in a 60 mL Single Dose Syringe, For IV Use, Rx Only KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674199

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

The hazard

Lack of Assurance of Sterility

What to do

FDA enforcement status: Terminated

Brands named

krs global biotechnologykrskrs global

Recall history

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

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