Drug product
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.
D-0079-2023
Product summary
- Event
- Event 91197
- Status
- Terminated
- Classification
- Class I
- Quantity
- 489,600 vials
- Official record key
drug-enforcement:D-0079-2023
Official wording
Reason: Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
Code information: Lots: P0001178 Exp. 05/2023; P0001298, P0001301, P0001313, P0001314, P0001317 Exp. 08/2023; P0001330, P0001464 Exp. 09/2023; P0001442 Exp. 11/2023; P0001467, P0001472, P0001486, P0001532 Exp. 12/2023.
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Unknown
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.