Sodium Bicarbonate in 5% Dextrose Injection recalled over sterility concerns

Recall date

August 10, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

SterRx, LLC recalls Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL bags, Rx only, SterRx, 141…

Recall number

D-0767-2021

FDA classification

Class I

Brand / firm

SterRx, LLC

Sold / distributed

Nationwide in the US

Why it was recalled

Non-Sterility: firm's third party lab confirmed microbial contamination.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903 NDC 70324-326-01