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Recall Observatory FDA recall evidence

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

December 12, 2013

Class I

Product summary

Firm
Zions RX Formulations Services LLC dba RX Formuations Serv.
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

    reason.microbial_contamination · v1.0.0

    microbial contamination