Sodium Bicarbonate Injection Recalled Due to Sterility Assurance Issue
Exela Pharma Sciences is recalling Sodium Bicarbonate 8.4% Injection due to lack of sterility assurance. The recall affects approximately 103,950 vials nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II with lack of sterility assurance in an injectable product constitutes a risk-of-harm where injury has not been reported. Per the rubric, such products score 3. The theoretical nature of the hazard and absence of reported illnesses preclude a higher score.
Plain-English summary
Exela Pharma Sciences LLC is recalling Sodium Bicarbonate 8.4% Injection, USP, in 50 mL single-dose vials (1 mEq/mL). The affected lots are 10006417 and 10006418, with an expiration date of November 30, 2026.
The recall is due to lack of assurance of sterility for the affected lots.
Approximately 103,950 vials were distributed nationwide.
The recalled product
- Product
- SODIUM BICARBONATE (SODIUM BICARBONATE)
- Brand
- SODIUM BICARBONATE
- Manufacturer
- Exela Pharma Sciences LLC
- Category
- Drug — Injectable
- Affected units
- 103,950
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)
- Lots: 10006417 and 10006418
- Exp. 11/30/2026
Distribution
Distributed nationwide across the United States.
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