Drug product
Calcium Gluconate 10% for Injection, SDV 100 mL SDV, PF, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ, 85205.
D-1213-2014
Product summary
- Event
- Event 67080
- Status
- Terminated
- Classification
- Class I
- Quantity
- 450 Vials
- Official record key
drug-enforcement:D-1213-2014
Official wording
Reason: Non-Sterility: RX Formulation initiated this recall due to a report of microbial contamination found in Calcium Gluconate saturated solution that was observed upon drawing the vial contents into a syringe.
Code information: Lot #: 117433@15 Expiration Date: 12/07/2013 Lot #: 117446@8 Expiration Date: 12/12/2013 Lot#: 117923@8 Expiration Date: 12/19/2013
Distribution pattern: AZ
Derived failure modes
-
Microbial contamination
microbial contamination