Calcium Gluconate 10% for Injection — Class I drug recall D-1213-2014
Terminated recall by Zions RX Formulations Services LLC dba RX Formuations Serv., reported 2014-04-16, distributed in AZ. Non-Sterility: RX Formulation initiated this recall due to a report of microbial contamination found in Calciu
| Recall number | D-1213-2014 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zions RX Formulations Services LLC dba RX Formuations Serv., Mesa, AZ, United States |
| Recall initiated | 2013-12-12 |
| Classified | 2014-04-07 |
| Reported by FDA | 2014-04-16 |
| Terminated | 2014-05-01 |
| Distributed | AZ |
| Quantity | 450 vials |
| Reason classes | microbial contamination, sterility |
| Expiration dates | 2013-12-07, 2013-12-12, 2013-12-19 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1213-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.