Drug product
8.4% Sodium Bicarbonate Injection, USP, 1 mEq/mL, 4.2 g/50 mL (84 mg/mL), 1 x 50 mL Pre-Filled Syringe, packaged in a) 10 x 1 syringe carton, b) 30 x 1 syringe carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-214-50
D-0950-2022
Product summary
- Event
- Event 90211
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13612 syringes
- Official record key
drug-enforcement:D-0950-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots: SB2001A, Exp. 1/2/2023; SB2005B, SB2005C, Exp. 3/8/2023; SB2006A, SB2006B, SB2006C, Exp. 3/16/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility