Drug product
Calcium Gluconate Injection, USP 10%, 0.465 mEq Ca++/mL, 1 g/10 mL (100 mg/mL), 10 mL Pre-Filled Syringe, 5 x 10 Pre-filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-950-10
D-0951-2022
Product summary
- Event
- Event 90211
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30180 syringes
- Official record key
drug-enforcement:D-0951-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots: CG1003A, Exp. 12/3/2022; CG2001A, Exp. 2/10/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility