Exela Pharma Sciences LLC: Drug Recall
Recall #D-0369-2022 · 01/11/2022
Class II: Risk
Recall Details
- Recall Number
- D-0369-2022
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Exela Pharma Sciences LLC
- Status
- Terminated
- Date Initiated
- 01/11/2022
- Location
- Lenoir, NC, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18,960 vials
Reason for Recall
Lack of Assurance of Sterility
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
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.