Recall D-0369-2022
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
Recall D-0369-2022 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0369-2022 |
Event ID | 89402 |
Distribution | Nationwide within the United States |
Quantity | 18,960 vials |
Recall Reason | Lack of Assurance of Sterility |
Drug Classification | Class II |
Drug Code Info | 20220119 |
Recall Initiation Date | 20220111 |
Report Date | 20220119 |
Classification Date | 20220113 |
Address | 1245 Blowing Rock Blvd Lenoir, NC 28645-3618 United States |
Recalling Firm | Exela Pharma Sciences LLC |
Initial Notification | Letter |
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