CLASS I Drug recall · Reported 16 Apr 2014 · FDA Enforcement Report

Calcium Gluconate 10% for Injection, SDV, PF recalled

Zions RX Formulations Services is recalling Calcium Gluconate 10% for Injection, SDV, PF, Not for Dispensing, For Hospital, distributed in Arizona. The recall was initiated on 12 Dec 2013 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesLot #: 117433@15 Expiration Date: 12/07/2013 Lot #: 117446@8 Expiration Date: 12/12/2013 Lot#: 117923@8 Expiration Date: 12/19/2013

Quantity recalled450 Vials

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-1213-2014
FDA event ID: 67080
Recalling firm: Zions RX Formulations Services, Mesa, AZ
Classification: Class I
Status: Terminated
Recall initiated: 12 Dec 2013
FDA classified: 7 Apr 2014
Reported: 16 Apr 2014
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Sterility
Drug class: Injectable & IV Drugs

Timeline

12 Dec 2013	Recall initiated by company
7 Apr 2014	Classified by FDA	+116 days
16 Apr 2014	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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.

Where it was distributed

Arizona

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

6 other products · FDA event 67080

This product is part of a recall event; the main page for the event is Bupivacaine 3% units, Not for Dispensing recalled.

Reported	Class	Recall	Company	Reason	Where
16 Apr 2014	CLASS II	Bupivacaine 3% units, Not for Dispensing recalled	Zions RX Formulations Services	Sterility	AZ
16 Apr 2014	CLASS II	Potassium Phosphates 4.4mEq//mL Vials, Not for Dispensing recalled	Zions RX Formulations Services	Sterility	AZ
16 Apr 2014	CLASS II	Magnesium Sulfate 10gm in Lactated Ringers recalled	Zions RX Formulations Services	Sterility	AZ
16 Apr 2014	CLASS II	Vitamin B-12 injections, a) and b) units recalled	Zions RX Formulations Services	Sterility	AZ
16 Apr 2014	CLASS II	Oxytocin in Sodium Chloride 0.9%, Not for Dispensing recalled	Zions RX Formulations Services	Sterility	AZ
16 Apr 2014	CLASS II	Sodium Bicarbonate 8.4%, a), b), and c) units recalled	Zions RX Formulations Services	Sterility	AZ

More recalls from Zions RX Formulations Services

All 7

Reported	Class	Recall	Company	Reason	Where
16 Apr 2014Drug	CLASS II	Sodium Bicarbonate 8.4%, a), b), and c) units recalled	Zions RX Formulations Services	Sterility	AZ
16 Apr 2014Drug	CLASS II	Oxytocin in Sodium Chloride 0.9%, Not for Dispensing recalled	Zions RX Formulations Services	Sterility	AZ
16 Apr 2014Drug	CLASS II	Vitamin B-12 injections, a) and b) units recalled	Zions RX Formulations Services	Sterility	AZ
16 Apr 2014Drug	CLASS II	Magnesium Sulfate 10gm in Lactated Ringers recalled	Zions RX Formulations Services	Sterility	AZ
16 Apr 2014Drug	CLASS II	Potassium Phosphates 4.4mEq//mL Vials, Not for Dispensing recalled	Zions RX Formulations Services	Sterility	AZ

Other Calcium Gluconate recalls

All 8

Reported	Class	Recall	Company	Reason	Where
8 Jun 2022Drug	CLASS II	Calcium Gluconate Injection, USP 10%, 0.465 mEq Ca++/mL recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
7 Nov 2018Drug	CLASS II	Calcium Gluconate 10%, 100 mg/mL Injectable recalled	Pharm D Solutions	Sterility	Nationwide
5 Sep 2018Drug	CLASS II	Calcium Gluconate injectable, 10% Single Dose vial recalled	Auro Pharmacies	Sterility	Nationwide
11 Jan 2017Drug	CLASS II	Calcium Gluconate 10% Injection recalled by Tri-Coast Pharmacy	Tri-Coast Pharmacy	Sterility	Nationwide
9 Dec 2015Drug	CLASS II	Calcium Gluconate 10% Injection, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide