Recall archive / FDA drug enforcement

Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL Single Dose bag, package... — FDA record D-0930-2023

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jul 7, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

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
Classification: Class II
Recalling firm: SterRx, LLC
Quantity: 137,304 bags
Agency-reported status: Terminated
Source record identifier: D-0930-2023

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	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; 498443, 498451, Exp 12-Dec-23; 498460, Exp 13-Dec-23; 498478, Exp 14-Dec-23; 498507, Exp 24-Jan-24; 498515, 498523, Exp 25-Jan-24; 498531, 498540, Exp 26-Jan-24; 498558, Exp 27-Jan-24; 498574, Exp 30-Jan-24; 498582, 499665, Exp 31-Jan-24; 500355, 500363, Exp 1-Feb-24; 500371, 500380, Exp 2-Feb-24; 500398, 500401, Exp 3-Feb-24; 500419, 500427, Exp 6-Feb-24; 500435, 500443, Exp 7-Feb-24; 500451, 500460, Exp 8-Feb-24; 500478, Exp 9-Feb-24

Label field

Details supplied by the agency

Lot, code or applicability

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; 498443, 498451, Exp 12-Dec-23; 498460, Exp 13-Dec-23; 498478, Exp 14-Dec-23; 498507, Exp 24-Jan-24; 498515, 498523, Exp 25-Jan-24; 498531, 498540, Exp 26-Jan-24; 498558, Exp 27-Jan-24; 498574, Exp 30-Jan-24; 498582, 499665, Exp 31-Jan-24; 500355, 500363, Exp 1-Feb-24; 500371, 500380, Exp 2-Feb-24; 500398, 500401, Exp 3-Feb-24; 500419, 500427, Exp 6-Feb-24; 500435, 500443, Exp 7-Feb-24; 500451, 500460, Exp 8-Feb-24; 500478, Exp 9-Feb-24

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Nationwide in the USA

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Jul 26, 2023
Recall initiation date: Jul 7, 2023
Center classification date: Jul 19, 2023
Termination date: Jul 8, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.