Sodium Bicarbonate 8 — Class II drug recall D-1217-2014
Terminated recall by Zions RX Formulations Services LLC dba RX Formuations Serv., reported 2014-04-16, distributed in AZ. Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assur
| Recall number | D-1217-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| 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 | 610 units |
| Reason classes | sterility |
| Expiration dates | 2013-12-12, 2013-12-18, 2013-12-19, 2013-12-25 |
Product
Sodium Bicarbonate 8.4%, a) 10 mL, b) 20 mL, and c) 22 mL units, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205
Reason for recall
Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.
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-1217-2014. 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.