Agency classClass IOur severity:Severe FDA (Drugs)·D-0767-2021·Announced 2021-09-01

SterRx Sodium Bicarbonate Injection Recalled for Non-Sterility

SterRx is recalling Sodium Bicarbonate in 5% Dextrose Injection due to microbial contamination confirmed by third-party laboratory testing. The affected product is a prescription intravenous injection distributed nationwide.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class I recall of a sterile injectable drug with confirmed microbial contamination. Non-sterile intravenous products pose direct risk of serious infection, sepsis, or other life-threatening complications in patients, even without reported illnesses stated in the source text.

Plain-English summary

SterRx, LLC is recalling Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), in 1,000 mL bags (NDC 70324-326-01). The recall was initiated because a third-party laboratory confirmed microbial contamination in the product, meaning the solution is not sterile as required for intravenous injection.

Lot Number BUP with expiration date 03/23/22 is affected. Approximately 1,098 bags were distributed nationwide in the United States as a prescription-only medication.

Patients and healthcare providers who have received or are using this product should stop use immediately and consult with a healthcare professional about potential exposure. Healthcare facilities should quarantine and return remaining inventory of the affected lot to the manufacturer.

The recalled product

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 12903 NDC 70324-326-01
Manufacturer: SterRx, LLC
Category: Drug — Intravenous Injection
Hazard: non-sterility
microbial-contamination
Affected units: 1,098

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by SterRx, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · SterRx, LLC

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