Drug product
Calcium Gluconate 10% Injection (30 ML). Compounded by Tri-Coast Pharmacy
D-0254-2017
Product summary
- Event
- Event 75763
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 12 vials
- Official record key
drug-enforcement:D-0254-2017
Official wording
Reason: Lack of Assurance of Sterility
Code information: Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 08172016A (02/13/2017).
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility