NY manufacturer SterRx recalls 3 lots of sodium bicarbonate because of microbial contamination

Sodium Bicarbonate injection
Because of microbial contamination, three lots of sodium bicarbonate have been recalled by SterRx, a New York BFS manufacturer. (Fierce Pharma)

A fast-growing manufacturing facility in Plattsburgh, N.Y., near the Vermont border, has recalled three lots of sodium bicarbonate because of waterborne microbial contamination.

The recall by SterRx, a producer of sterile liquid compounds, is ro4 sodium bicarbonate 5% dextrose injection packaged in 1000 ml IV bags. The drug is used to treat a variety of maladies including uncontrolled diabetes, irregular heartbeat, lactic acidosis, cardiac arrest, some drug intoxications and severe cases of dehydration, diarrhea and renal disease. 

SterRx self-reported the contamination, but didn’t reveal how it happened. The company initiated the recall to the hospital pharmacy level. Use of the product, if not sterile, could lead to systemic infections that could be life threatening. No adverse events have been reported.

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The three lots were shipped in May and June of this year and carried expiration dates of June 2022.    

SterRx was founded in 2013 as a breakout from Asept Pak, another blow-fill-seal manufacturer located an hour to the west in Malone, N.Y. SterRx uses robotic automation in its 50,000-square foot BFS plant set on the former Plattsburgh Air Force Base. 

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SterRx will soon also occupy a 60,000-square foot warehouse and distribution facility which is under construction. From 2015, the company has grown from 30 employees to 200, with plans for more additions when it takes up residence in the new site.