8.4% Sodium Bicarbonate Injection recall: Sterility Concern
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
Why was 8.4% Sodium Bicarbonate Injection recalled?
Lack of Assurance of Sterility
What should I do if I have this product?
Review the official FDA enforcement record for current 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?
Lot #: C0001088/P0001317, Exp. Date 08/2023
- 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
- Recalling firm
- Exela Pharma Sciences LLC
- Quantity
- 18,960 vials
- Distribution
- Nationwide within the United States
- Recall date
- January 19, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)