Class I Recall for Contaminated IV Bags

SterRx’s voluntary recall of three lots of sodium bicarbonate in 5% dextrose injection has been designated Class I by the US Food and Drug Administration (FDA), according to the September 1, 2021, FDA Enforcement Report. Use of products affected by a Class I recall could lead to serious adverse health consequences or death. 

The recall is due to waterborne microbial contamination of the product, SterRx announced in an August 10, 2021, statement.  

“Intravenous administration of sodium bicarbonate in 5% dextrose injection 150mEq per 1000 mL, intended to be sterile that is not sterile, could result in site-specific infections as well as serious systemic infections which may be life-threatening,” the company explained. “To date, SterRx has not received reports of any adverse events associated with this issue.”

The recall affects 1000-mL IV bags containing sodium bicarbonate in 5% dextrose injection, 150mEq per 1000 mL (12.6 mg per mL; NDC 70324-326-01), from lots BUP (Exp. 3/23/22), BUI (Exp. 3/16/22), and BTW (Exp. 3/8/22). The product was distributed to hospitals throughout the United States in May and June of 2021. 

SterRx voluntarily initiated the recall August 10, 2021. The FDA issued its Class I designation August 25, 2021. 

Sodium bicarbonate injection is a prescription treatment indicated for patients with high potassium, irregular heartbeat, or metabolic acidosis.