The Recall Desk
SevereFDA (Drugs)·D-0080-2023·Announced 2022-12-21

FDA Recalls Sodium Bicarbonate Injection Vials for Glass Breakage Risk

Exela Pharma Sciences is recalling Sodium Bicarbonate Injection vials due to defective containers that may break and release glass fragments when pressurized during preparation. The recall affects 37,320 vials distributed nationwide.

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: This is classified as FDA Class I, which per rubric guidance requires a minimum score of 4. The defective containers pose a risk of glass breakage and release during preparation, though no injuries have been reported in the source text.

Plain-English summary

Exela Pharma Sciences LLC is recalling 8.4% Sodium Bicarbonate Injection, USP (50 mEq/50 mL single-dose vials) due to defective containers. The affected lot is P0001490 with an expiration date of 12/2023. A total of 37,320 vials were distributed nationwide.

The vials have defective containers that can break and release glass fragments when pressurized during preparation for administration. The FDA has received complaints of vial breakage and glass flying when the product is pressurized while being prepared for use.

Healthcare providers who have this product should not administer it and should return it to their supplier or dispose of it safely.

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
Hazard
Affected units
37,320

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 (1)

  • Lot: P0001490 Exp. 12/2023

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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