FDA Drug recall D-1213-2014
Calcium Gluconate 10% for Injection, SDV 100 mL SDV, PF, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East U…
- FDA Drug
- Class I
- terminated
- Published 2014-04-16
On 2014-04-16 the FDA classified a Class I recall of Calcium Gluconate 10% for Injection, SDV 100 mL SDV, PF, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East U… by Zions Rx Formulations Services, citing 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 via….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1213-2014 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2013-12-12 |
| Published | 2014-04-16 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Zions Rx Formulations Services |
| Distribution | AZ |
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
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.
Identifiers
| code_info | Lot #: 117433@15 Expiration Date: 12/07/2013 Lot #: 117446@8 Expiration Date: 12/12/2013 Lot#: 117923@8 Expiration Date: 12/19/2013 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1213-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.