Medications & Supplements/Prescription Drugs

Exela and Civica Sodium Bicarbonate Injection Recalled for Vial Breakage Risk

Agency Publication Date: October 27, 2022

Summary

Exela Pharma Sciences LLC is recalling approximately 2,271,960 vials of 8.4% Sodium Bicarbonate Injection (USP) under the Exela and Civica brands. The recall was initiated because of reports that the glass vials can shatter when pressurized during the preparation process. This defect creates a danger of flying glass fragments, and complaints of vial breakage have already been received. These products were distributed to hospitals, pharmacies, and healthcare facilities nationwide.

Risk

The glass vials used for this injection can shatter unexpectedly when pressurized during medical use, posing a serious risk of injury from flying glass fragments to both healthcare professionals and patients.

What You Should Do

This recall affects 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials sold under the Exela and Civica brands.
Identify affected products by checking for NDC codes 51754-5001-1, 51754-5001-5, 72572-740-1, or 72572-740-20. See the Affected Products section below for the full list of affected lot numbers and expiration dates.
Stop using the recalled product immediately and quarantine all remaining stock in your facility.
Contact Exela Pharma Sciences LLC or your distributor to arrange for the return of the recalled vials.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions or need to report an incident.

Your Remedy Options

Other Action

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: 8.4% Sodium Bicarbonate Injection, USP (Exela Brand)by Exela

Variants: 50 mEq/50 mL (1 mEq/mL), 50 mL Single Dose Vial

Lot Numbers:

P0001370 (Exp. 10/2023)

P0001371 (Exp. 10/2023)

P0001372 (Exp. 10/2023)

P0001433 (Exp. 11/2023)

P0001434 (Exp. 11/2023)

P0001443 (Exp. 12/2023)

P0001468 (Exp. 12/2023)

P0001469 (Exp. 12/2023)

P0001470 (Exp. 12/2023)

P0001495 (Exp. 12/2023)

P0001505 (Exp. 12/2023)

P0001506 (Exp. 12/2023)

P0001509 (Exp. 12/2023)

P0001510 (Exp. 12/2023)

P0001511 (Exp. 12/2023)

P0001512 (Exp. 12/2023)

P0001560 (Exp. 01/2024)

P0001561 (Exp. 01/2024)

P0001562 (Exp. 01/2024)

P0001564 (Exp. 01/2024)

P0001566 (Exp. 01/2024)

P0001567 (Exp. 01/2024)

P0001568 (Exp. 01/2024)

P0001571 (Exp. 02/2024)

P0001572 (Exp. 02/2024)

P0001573 (Exp. 02/2024)

P0001574 (Exp. 02/2024)

P0001578 (Exp. 02/2024)

P0001579 (Exp. 02/2024)

P0001580 (Exp. 02/2024)

P0001583 (Exp. 02/2024)

P0001586 (Exp. 02/2024)

P0001587 (Exp. 02/2024)

P0001588 (Exp. 02/2024)

P0001593 (Exp. 02/2024)

P0001594 (Exp. 02/2024)

P0001610 (Exp. 02/2024)

P0001618 (Exp. 02/2024)

P0001619 (Exp. 02/2024)

P0001654 (Exp. 02/2024)

P0001644 (Exp. 03/2024)

P0001645 (Exp. 03/2024)

P0001646 (Exp. 03/2024)

P0001662 (Exp. 03/2024)

P0001664 (Exp. 03/2024)

P0001730 (Exp. 05/2024)

NDC:

51754-5001-5

51754-5001-1

Product: 8.4% Sodium Bicarbonate Injection, USP (Civica Brand)by Civica

Variants: 50 mEq/50 mL (1 mEq/mL), 50 mL Single Dose Vial

Lot Numbers:

P0001497 (Exp. 12/2023)

P0001600 (Exp. 02/2024)

P0001663 (Exp. 03/2024)

NDC:

72572-740-20

72572-740-1

Product Images

Exela Carton NDC: 51754-5001-5; Vial NDC: 51754-5001-1 label

Civica Carton NDC: 72572-740-20; Vial NDC: 72572-740-1 label

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90956

Status: Resolved

Manufacturer: Exela Pharma Sciences LLC

Sold By: Hospitals; Pharmacies; Healthcare facilities

Manufactured In: United States

Units Affected: 2 products (2,123,040 vials; 148,920)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · FDA Press Release · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials sold under the Exela and Civica brands.

Identify affected products by checking for NDC codes 51754-5001-1, 51754-5001-5, 72572-740-1, or 72572-740-20. See the Affected Products section below for the full list of affected lot numbers and expiration dates.

Stop using the recalled product immediately and quarantine all remaining stock in your facility.

Contact Exela Pharma Sciences LLC or your distributor to arrange for the return of the recalled vials.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions or need to report an incident.

Affected Products

Product: 8.4% Sodium Bicarbonate Injection, USP (Exela Brand)by Exela

Variants: 50 mEq/50 mL (1 mEq/mL), 50 mL Single Dose Vial

Lot Numbers:

P0001370 (Exp. 10/2023)

P0001371 (Exp. 10/2023)

P0001372 (Exp. 10/2023)

P0001433 (Exp. 11/2023)

P0001434 (Exp. 11/2023)

P0001443 (Exp. 12/2023)

P0001468 (Exp. 12/2023)

P0001469 (Exp. 12/2023)

P0001470 (Exp. 12/2023)

P0001495 (Exp. 12/2023)

P0001505 (Exp. 12/2023)

P0001506 (Exp. 12/2023)

P0001509 (Exp. 12/2023)

P0001510 (Exp. 12/2023)

P0001511 (Exp. 12/2023)

P0001512 (Exp. 12/2023)

P0001560 (Exp. 01/2024)

P0001561 (Exp. 01/2024)

P0001562 (Exp. 01/2024)

P0001564 (Exp. 01/2024)

P0001566 (Exp. 01/2024)

P0001567 (Exp. 01/2024)

P0001568 (Exp. 01/2024)

P0001571 (Exp. 02/2024)

P0001572 (Exp. 02/2024)

P0001573 (Exp. 02/2024)

P0001574 (Exp. 02/2024)

P0001578 (Exp. 02/2024)

P0001579 (Exp. 02/2024)

P0001580 (Exp. 02/2024)

P0001583 (Exp. 02/2024)

P0001586 (Exp. 02/2024)

P0001587 (Exp. 02/2024)

P0001588 (Exp. 02/2024)

P0001593 (Exp. 02/2024)

P0001594 (Exp. 02/2024)

P0001610 (Exp. 02/2024)

P0001618 (Exp. 02/2024)

P0001619 (Exp. 02/2024)

P0001654 (Exp. 02/2024)

P0001644 (Exp. 03/2024)

P0001645 (Exp. 03/2024)

P0001646 (Exp. 03/2024)

P0001662 (Exp. 03/2024)

P0001664 (Exp. 03/2024)

P0001730 (Exp. 05/2024)

NDC:

51754-5001-5

51754-5001-1

Product: 8.4% Sodium Bicarbonate Injection, USP (Civica Brand)by Civica

Variants: 50 mEq/50 mL (1 mEq/mL), 50 mL Single Dose Vial

Lot Numbers:

P0001497 (Exp. 12/2023)

P0001600 (Exp. 02/2024)

P0001663 (Exp. 03/2024)

NDC:

72572-740-20

72572-740-1