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 |
| Similar To |