Calcium Gluconate 10% for Injection recall: Sterility Concern
Calcium Gluconate 10% for Injection, SDV 100 mL SDV, PF, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University…
Why was Calcium Gluconate 10% for Injection 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models 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
- Product
- Calcium Gluconate 10% for Injection, SDV 100 mL SDV, PF, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University…
- Recalling firm
- Zions RX Formulations Services LLC dba RX Formuations Serv.
- Quantity
- 450 Vials
- Distribution
- AZ
- Recall date
- April 16, 2014
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (drug)