Exela Pharma Sciences LLC: Drug Recall
Recall #D-0022-2023 · 10/04/2022
Class I: Dangerous
Recall Details
- Recall Number
- D-0022-2023
- Classification
- Class I
- Product Type
- Drug
- Recalling Firm
- Exela Pharma Sciences LLC
- Status
- Terminated
- Date Initiated
- 10/04/2022
- Location
- Lenoir, NC, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,123,040 vials
Reason for Recall
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration
Product Description
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx only, Manufactured and Distributed by: Exela Pharma Sciences, LLC Lenoir, NC 28645. Carton NDC 51754-5001-5, vial NDC 51754-5001-1
Distribution Pattern
Nationwide within the United States
Other Recalls by Exela Pharma Sciences LLC
- Class II: Risk 07/30/2025
- Class II: Risk 03/07/2025
- Class I: Dangerous 10/18/2023
- Class I: Dangerous 10/18/2023
- Class I: Dangerous 10/18/2023
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.