Sodium Bicarbonate in 5% Dextrose Injection — Class II drug recall D-0930-2023
Terminated recall by SterRx, LLC, reported 2023-07-26, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-0930-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SterRx, LLC, Plattsburgh, NY, United States |
| Recall initiated | 2023-07-07 |
| Classified | 2023-07-19 |
| Reported by FDA | 2023-07-26 |
| Terminated | 2024-07-08 |
| Distributed | Nationwide (US) |
| Quantity | 137,304 bags |
| Reason classes | sterility |
| NDC | 70324-0326-01 |
| Lot numbers | 489344, 489352, 489361, 489387, 491647, 492181, 492199, 492201, 492210, 492228, 492236, 492244, 492261, 492279, 492287, 492295, 492308, 492957, 492965, 492973, 492981, 494194, 494207, 494215, 494223, 494231, 495200, 495218, 495453, 495470, 495488, 495496, 495509, 495517, 495525, 495533, 495699, 495701, 495710, 495728 and 46 more |
| Expiration dates | 2023-07-25, 2023-07-26, 2023-07-27, 2023-07-28, 2023-07-29, 2023-08-02, 2023-08-03, 2023-08-04, 2023-08-05, 2023-08-08, 2023-08-09, 2023-09-19, 2023-09-20, 2023-09-21, 2023-09-22, 2023-09-23, 2023-09-26, 2023-09-27, 2023-09-28, 2023-09-29, 2023-09-30, 2023-10-03, 2023-10-04, 2023-11-15, 2023-11-16 and 26 more |
Product
Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL Single Dose bag, packaged in 1000 mL x 6 units per case, 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-0930-2023. 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.