Home / Recalls / Zions RX Formulations Services LLC dba RX Formuations Serv. / D-1213-2014

D-1213-2014 Class I Terminated

Recalled by Zions RX Formulations Services LLC dba RX Formuations Serv. — Mesa, AZ

Recall Details

Product Type: Drugs
Report Date: April 16, 2014
Initiation Date: December 12, 2013
Termination Date: May 1, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 450 Vials

Product Description

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.

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.

Distribution Pattern

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

Other recalls by Zions RX Formulations Services LLC dba RX Formuations Serv.

D-1217-2014 Class II — Sodium Bicarbonate 8.4%, a) 10 mL, b) 20 mL, and c) 22 mL units, Not for Dispens (December 12, 2013)
D-1219-2014 Class II — Vitamin B-12 injections, a) 1 mL and b) 30 mL units, Not for Dispensing, For Hos (December 12, 2013)
D-1214-2014 Class II — Magnesium Sulfate 10gm in 250mL Lactated Ringers Bags, Not For Dispensing, For H (December 12, 2013)
D-1215-2014 Class II — Potassium Phosphates 4.4mEq/3mM/mL Vials, Not for Dispensing, For Hospital Admin (December 12, 2013)
D-1218-2014 Class II — Bupivacaine 3%, 300 mL units, Not for Dispensing, For Hospital Administration On (December 12, 2013)
D-1216-2014 Class II — Oxytocin 30 Units in 500mL Sodium Chloride 0.9% Bags, Not for Dispensing, For Ho (December 12, 2013)