Agency classClass IIOur severity:Severe FDA (Drugs)·D-0768-2021·Announced 2021-09-01

SterRx Sodium Bicarbonate in 5% Dextrose Injection Recalled for Sterility Concerns

SterRx is recalling Sodium Bicarbonate in 5% Dextrose Injection (1,000 mL bags) nationwide due to lack of assurance of sterility. Patients using affected lots should consult their healthcare provider immediately.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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: The FDA has classified this as a Class II recall. Lack of sterility assurance in an intravenous injection product presents a significant risk of serious adverse health consequences, meeting the criterion for Severe severity under the rubric.

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, distributed nationwide in the United States. The recall was initiated because the firm cannot assure the sterility of the affected product.

The recalled lots are: Lot BTW (expiration date 03/08/22) and Lot BUI (expiration date 03/16/22). A total of 3,378 bags are affected by this recall.

Sodium Bicarbonate in 5% Dextrose Injection is an intravenous medication used for medical purposes. Lack of sterility assurance poses a potential risk to patients who receive the product. Healthcare providers and patients who have this product should stop using it and contact their healthcare provider for guidance.

Patients or healthcare providers with questions about this recall should contact SterRx, LLC or the FDA.

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
Manufacturer: SterRx, LLC
Category: Drug — Injectable Solution
Hazard: lack-of-sterility
contamination-risk
Affected units: 3,378

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 (3)

Lot Numbers: BTW
exp. date 03/08/22 BUI
exp. date 03/16/22

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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