On August 10, 2021, the U.S. Food and Drug Administration (FDA) reported SterRx, LLC’s, voluntary recall of three lots of sodium bicarbonate in 5% dextrose injection 150 mEq per 1,000 ml due to waterborne microbial contamination.
IV administration of contaminated sodium bicarbonate in 5% dextrose injection could result in site-specific infections or serious, potentially life-threatening systemic infections, the company said. SterRx has not received any associated reports of adverse events.
The product is supplied in 1000 ml IV bags. The recall affects the following lots of sodium bicarbonate in 5% dextrose injection 150 mEq per 1,000 ml (12.6 mg per ml) that were distributed to hospitals nationwide from May–June 2021:
|NDC Number||Lot Number||Expiration Date||Distribution Dates|
|70324-326-01||BUP||3/23/2022||June 1–2, 2021|
|70324-326-01||BUI||3/16/2022||May 21–25, 2021|
|70324-326-01||BTW||3/08/2022||May 11–12, 2021|
Consumers have been instructed to examine their inventory immediately and to quarantine, discontinue distribution of, and return the recalled product. Consumers who have questions, concerns, or reports of adverse events should consult their healthcare provider and SterRx’s customer call center at 518-324-7879, extension 207, Monday–Friday from 8 am–5 pm (ET).
Healthcare professionals and consumers who have medical questions about the recalled product should contact SterRx at 518-324-7879, extension 216, Monday–Friday from 8 am–5 pm (ET). Any adverse reactions or quality problems experienced while using the product should be reported to MedWatch, FDA’s Safety Information and Adverse Event Reporting Program.