D-0369-2022 Class II Terminated
FDA drug recall D-0369-2022 was initiated by Exela Pharma Sciences LLC on January 11, 2022 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated December 2, 2022). Affected quantity: 18,960 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- January 19, 2022
- Initiation Date
- January 11, 2022
- Termination Date
- December 2, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18,960 vials
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
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: C0001088/P0001317, Exp. Date 08/2023