8.4% Sodium Bicarbonate Injection recall: Sterility Concern
8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose Vials per carton, For Intravenous Use Only, Rx Only…
Why was 8.4% Sodium Bicarbonate Injection recalled?
Lack of Assurance of Sterility
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lots: 10006417 and 10006418, Exp. 11/30/2026
- Product
- 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose Vials per carton, For Intravenous Use Only, Rx Only…
- Recalling firm
- Exela Pharma Sciences LLC
- Quantity
- 103,950 vials
- Distribution
- Nationwide
- Recall date
- April 2, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)