Drug product
Calcium Gluconate1% Eyewash 10 mg/mL, 125 mL bottles, Pharm D Solutions, Houston, Texas ---- NDC 69699-0906-12
D-0147-2019
Product summary
- Event
- Event 81002
- Status
- Terminated
- Classification
- Class II
- Quantity
- 29 bottles
- Official record key
drug-enforcement:D-0147-2019
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots: 05072018:46 Discard by: 5/1/2019; 07122018:30 Discard by: 7/7/2019
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility