FDAClass ISeptember 1, 2021

Sodium Bicarbonate in 5% Dextrose Injection recall: Sterility Concern

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…

Why was Sodium Bicarbonate in 5% Dextrose Injection recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Number: BUP, exp. date 03/23/22

Product
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…
Recalling firm
SterRx, LLC
Quantity
1098 bags
Distribution
Nationwide in the US
Recall date
September 1, 2021
Classification
Class I
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls