The Recall Desk
SevereFDA (Drugs)·D-0023-2023·Announced 2022-11-02

Sodium Bicarbonate Injection Recalled for Defective Vials and Glass Breakage

Nationwide recall of 8.4% sodium bicarbonate injection vials due to container defects causing vial breakage and glass fragments when pressurized during preparation.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I classification requires a minimum severity score of 4. The defect—documented complaints of vial breakage and glass fragments during preparation—poses a hazard to patients and healthcare workers, but no deaths or serious injuries have been reported.

Plain-English summary

Exela Pharma Sciences LLC is recalling 8.4% Sodium Bicarbonate Injection, USP (50 mEq/50 mL single-dose vials) nationwide in the United States. The recall affects three lots: P0001497 (expires 12/2023), P0001600 (expires 02/2024), and P0001663 (expires 03/2024). Approximately 148,920 units are involved.

The product is being recalled due to defective containers. Complaints have been received reporting vial breakage and glass fragments when the product is pressurized during preparation for administration.

Healthcare providers and patients who have received this product should consult with their healthcare provider regarding potential exposure and appropriate medical evaluation if needed. The product should not be used. Patients or healthcare providers should contact Civica, Inc. or the FDA with any questions or to report adverse events.

The recalled product

Product
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx Only, Mfd for: Civica, Inc. Lehi, Utah 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645, Carton NDC 72572-740-20, vial NDC 72572-740-1.
Manufacturer
Exela Pharma Sciences LLC
Category
Drug — Intravenous Injection
Hazard
Affected units
148,920

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 #: P0001497 Exp. 12/2023
  • P0001600 Exp. 02/2024
  • P0001663 Exp. 03/2024

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Exela Pharma Sciences 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 →

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