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
Reported: January 19, 2022 Initiated: January 11, 2022 #D-0369-2022
Product Description
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
Reason for Recall
Lack of Assurance of Sterility
Details
- Recalling Firm
- Exela Pharma Sciences LLC
- Units Affected
- 18,960 vials
- Distribution
- Nationwide within the United States
- Location
- Lenoir, NC
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Exela Pharma Sciences LLC. Units affected: 18,960 vials.
Why was this product recalled? ▼
Lack of Assurance of Sterility
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 19, 2022. Severity: Moderate. Recall number: D-0369-2022.
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