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, Mfd for: Civica, Inc. Lehi, Utah 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645, Carton NDC 72572-740-20, vial NDC 72572-740-1.
D-0080-2023
Product summary
- Event
- Event 91197
- Status
- Terminated
- Classification
- Class I
- Quantity
- 37,320 vials
- Official record key
drug-enforcement:D-0080-2023
Official wording
Reason: Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
Code information: Lot: P0001490 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.