Medications & Supplements/Prescription Drugs

8.4% Sodium Bicarbonate Injection Recalled for Vial Breakage and Glass Risk

Agency Publication Date: December 13, 2022

Summary

Exela Pharma Sciences, LLC and Civica, Inc. have recalled approximately 526,920 vials of 8.4% Sodium Bicarbonate Injection, USP. The recall was issued because the vials may break or shatter, sending glass flying when the product is pressurized during medical preparation. Healthcare providers and pharmacies should stop using the affected lots immediately to avoid injury or contamination.

Risk

The defective vials can shatter when pressurized, posing a risk of physical injury from flying glass fragments to healthcare professionals and potential glass contamination of the medication.

What You Should Do

This recall affects 8.4% Sodium Bicarbonate Injection, USP (50 mEq/50 mL) single-dose vials manufactured by Exela Pharma Sciences, LLC and distributed under both the Exela and Civica brands.
To identify the product, check the vial and carton 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. Contact the manufacturer or your distributor to arrange return.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

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 50 mEq/50 mL (1 mEq/mL)by Exela Pharma Sciences, LLC

Variants: 50 mL Single Dose Vial, Cartons of 20 vials

Lot Numbers:

P0001178 (Exp. 05/2023)

P0001298 (Exp. 08/2023)

P0001301 (Exp. 08/2023)

P0001313 (Exp. 08/2023)

P0001314 (Exp. 08/2023)

P0001317 (Exp. 08/2023)

P0001330 (Exp. 09/2023)

P0001464 (Exp. 09/2023)

P0001442 (Exp. 11/2023)

P0001467 (Exp. 12/2023)

P0001472 (Exp. 12/2023)

P0001486 (Exp. 12/2023)

P0001532 (Exp. 12/2023)

NDC:

51754-5001-5

51754-5001-1

Quantity: 489,600 vials

Product: 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL)by Civica, Inc.

Variants: 50 mL Single Dose Vial, Cartons of 20 vials

Lot Numbers:

P0001490 (Exp. 12/2023)

NDC:

72572-740-20

72572-740-1

Quantity: 37,320 vials

Product Images

Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial, Carton NDC: 51754-5001-5; Vial NDC: 51754-5001-1

Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial, Carton NDC: 72572-740-20; Vial NDC: 72572-740-1

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91197

Status: Resolved

Manufacturer: Exela Pharma Sciences LLC

Sold By: Civica, Inc.; Exela Pharma Sciences, LLC

Manufactured In: United States

Units Affected: 2 products (489,600 vials; 37,320 vials)

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) single-dose vials manufactured by Exela Pharma Sciences, LLC and distributed under both the Exela and Civica brands.

To identify the product, check the vial and carton 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. Contact the manufacturer or your distributor to arrange return.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Affected Products

Product: 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL)by Exela Pharma Sciences, LLC

Variants: 50 mL Single Dose Vial, Cartons of 20 vials

Lot Numbers:

P0001178 (Exp. 05/2023)

P0001298 (Exp. 08/2023)

P0001301 (Exp. 08/2023)

P0001313 (Exp. 08/2023)

P0001314 (Exp. 08/2023)

P0001317 (Exp. 08/2023)

P0001330 (Exp. 09/2023)

P0001464 (Exp. 09/2023)

P0001442 (Exp. 11/2023)

P0001467 (Exp. 12/2023)

P0001472 (Exp. 12/2023)

P0001486 (Exp. 12/2023)

P0001532 (Exp. 12/2023)

NDC:

51754-5001-5

51754-5001-1

Quantity: 489,600 vials

Product: 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL)by Civica, Inc.

Variants: 50 mL Single Dose Vial, Cartons of 20 vials

Lot Numbers:

P0001490 (Exp. 12/2023)

NDC:

72572-740-20

72572-740-1

Quantity: 37,320 vials