Sodium Bicarbonate in 5% Dextrose Injection — Class II drug recall D-0306-2022
Terminated recall by SterRx, LLC, reported 2022-01-05, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-0306-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SterRx, LLC, Plattsburgh, NY, United States |
| Recall initiated | 2021-11-12 |
| Classified | 2021-12-29 |
| Reported by FDA | 2022-01-05 |
| Terminated | 2023-12-06 |
| Distributed | Nationwide (US) |
| Quantity | 127,260 bags |
| Reason classes | sterility |
| NDC | 70324-0326-01 |
| Model numbers | S21363/CAW, S21366/CAZ, S21374/CBH, S21376/CBJ, S21377/CBK, S21381/CBO, S21384/CBR, S21387/CBU, S21390/CBX, S21392/CBZ, S21393/CCA, S21396/CCD, S21397/CCF, S21399/CCH, S21401/CCJ, S21404/CCM |
Product
Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1000 mL (12.6 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-326-01.
Reason for recall
Lack of Assurance of Sterility
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-0306-2022. 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.