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.
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 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
- Hazard
- sterility-failure
- infection-risk
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.
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