FDA Drug recall D-0930-2023
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…
- FDA Drug
- Class II
- terminated
- Published 2023-07-26
On 2023-07-26 the FDA classified a Class II recall of 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… by Sterrx, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0930-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-07-07 |
| Published | 2023-07-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sterrx |
| Distribution | US |
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
Lack of Assurance of Sterility
Identifiers
| code_info | Lot #: 489344, Exp 25-Jul-23; 489352, Exp 26-Jul-23; 489361, Exp 27-Jul-23; 489387, 491647, Exp 28-Jul-23; 492181, Exp…Lot #: 489344, Exp 25-Jul-23; 489352, Exp 26-Jul-23; 489361, Exp 27-Jul-23; 489387, 491647, Exp 28-Jul-23; 492181, Exp 29-Jul-23; 492199, 492201, Exp 2-Aug-23; 492210, 492228, Exp 3-Aug-23; 492236, 492244, Exp 4-Aug-23; 492261, Exp 5-Aug-23; 492279, 492287, Exp 8-Aug-23; 492295, 492308, Exp 9-Aug-23; 492957, 492965, Exp 19-Sep-23; 492973, 492981, Exp 20-Sep-23; 494194, 494207, Exp 21-Sep-23;494215, 494223, Exp 22-Sep-23; 494231, 495200, Exp 23-Sep-23; 495218, 495453, Exp 26-Sep-23; 495470, 495488, Exp 27-Sep-23; 495496, 495509, Exp 28-Sep-23; 495517, 495525, Exp 29-Sep-23; 495533, Exp 30-Sep-23; 495699, 495701, Exp 3-Oct-23; 495710, 495728, Exp 4-Oct-23; 496106, 497491, Exp 15-Nov-23; 497504, 497512, Exp 16-Nov-23; 497521, 497539, Exp 22-Nov-23; 497547, 497555, Exp 23-Nov-23; 497563, Exp 24-Nov-23; 497571, Exp 29-Nov-23; 497598, Exp 30-Nov-23; 497619, 498363, Exp 1-Dec-23; 498371, 498380, 498398, Exp 5-Dec-23; 498401, Exp 6-Dec-23; 498419, 498427, Exp 7-Dec-23; 498435, Exp 8-Dec-23; 49 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0930-2023%22
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