Why it was recalled
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.
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.
Lot numbers, UPCs & expiration codes
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 it was sold
AZ
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1213-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Dec 12, 2013
- FDA report date
- Apr 16, 2014
- Quantity
- 450 Vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Zions RX Formulations Services LLC dba RX Formuations Serv.
Original FDA data
Every field from FDA enforcement report D-1213-2014, exactly as published.
Show all FDA fields
- City
- Mesa
- State
- AZ
- Status
- Terminated
- Country
- United States
- Event ID
- 67080
- Address
- 5949 E University Dr
- 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
- Postal code
- 85205-7435
- Report date
- Apr 16, 2014
- Product type
- Drugs
- Recall number
- D-1213-2014
- Classification
- Class I
- Recalling firm
- Zions RX Formulations Services LLC dba RX Formuations Serv.
- Product quantity
- 450 Vials
- Termination date
- May 1, 2014
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- AZ
- Recall initiation date
- Dec 12, 2013
- Initial firm notification
- Center classification date
- Apr 7, 2014