Drug product
Calcium Gluconate 10%, 100 mg/mL Injectable, Pharm D Solutions, Houston, Texas ---- NDC 69699-0914-30
D-0148-2019
Product summary
- Event
- Event 81002
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6850 milliliters
- Official record key
drug-enforcement:D-0148-2019
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots: 07312018:46 Discard by: 1/27/2019; 07262018:97 Discard by: 1/21/2019; 07122018:40 Discard by: 1/8/2019
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility