FDA Recall D-1213-2014

Zions RX Formulations Services LLC dba RX Formuations Serv. · Mesa, AZ

Class I — life-threatening Terminated 140 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

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.

Lot / code: Lot #: 117433@15 Expiration Date: 12/07/2013 Lot #: 117446@8 Expiration Date: 12/12/2013 Lot#: 117923@8 Expiration Date: 12/19/2013

Quantity: 450 Vials

Reason for recall

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.

Recall record

Recall number: D-1213-2014
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: AZ
Recall initiated: 2013-12-12
Classified by FDA Center: 2014-04-07
FDA published: 2014-04-16
Terminated: 2014-05-01
Recalling firm: Zions RX Formulations Services LLC dba RX Formuations Serv.
Firm location: Mesa, AZ

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