Drug product
Calcium Gluconate 1% Eyewash Oph. Soln, 10 mg/mL, 1000 mL bottles, Pharm D Solutions, Houston, Texas ---- NDC 69699-0907-10
D-0146-2019
Product summary
- Event
- Event 81002
- Status
- Terminated
- Classification
- Class II
- Quantity
- 25 bottles
- Official record key
drug-enforcement:D-0146-2019
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots: 05072018:27 Discard by: 5/2/2019; 07122018:11 Discard by 7/7/2019
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility