The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0369-2022·Announced 2022-01-19

Exela Sodium Bicarbonate Injection Recalled for Sterility Assurance Failure

Exela Pharma Sciences is recalling 8.4% Sodium Bicarbonate Injection due to lack of assurance of sterility. The affected lot (C0001088/P0001317, expiring 08/2023) was distributed nationwide.

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: This is an FDA Class II drug recall involving a sterile injectable product where sterility cannot be assured. A non-sterile injection carries inherent risk of serious infection and patient harm. Although no illnesses or deaths are reported in the source text, the classification and nature of the defect (compromised sterility of an injection product) warrants a Severe designation per the rubric.

Plain-English summary

Exela Pharma Sciences, LLC is recalling 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) in 50 mL vials. The recall affects 18,960 vials of lot number C0001088/P0001317 with an expiration date of 08/2023. The manufacturer has not provided assurance of sterility for this product.

The affected product was distributed nationwide within the United States. Healthcare providers and patients who have received this product should be aware of this recall.

Consumers and healthcare professionals with questions about this recall should contact the FDA or the manufacturer for further information and guidance on next steps.

The recalled product

Product
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC., Lenoir, NC 28645, NDC 51754-5001-1
Manufacturer
Exela Pharma Sciences LLC
Category
Drug — Injectable / Injection Solution
Hazard
Affected units
18,960

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 (2)

  • Lot #: C0001088/P0001317
  • Exp. Date 08/2023

Distribution

Distributed nationwide across the United States.

Related recalls

Same manufacturer · Exela Pharma Sciences LLC

See all →

Same hazard · sterility failure

See all →

Similar recalls