Reported Apr 16, 2014 · Terminated
Calcium Gluconate 10% for Injection, SDV 100 mL SDV, PF, Not for Dispensing, For Hospital Administration Only, Rx…
Zions RX Formulations Services LLC dba RX Formuations Serv.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zions RX Formulations Services LLC dba RX Formuations Serv. · 5949 E University Dr · Mesa, AZ · 85205-7435
Is this the product you have?
- 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 codes and dates
- Lot #: 117433@15
- Expiration Date12/07/2013 Lot #: 117446@8
- Expiration Date12/12/2013 Lot#: 117923@8
- Expiration Date12/19/2013
- Amount recalled
- 450 Vials
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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