Medications & Supplements/Prescription Drugs

SterRx Sodium Bicarbonate and Norepinephrine Injections Recalled for Sterility

Agency Publication Date: July 19, 2023

Summary

SterRx, LLC has voluntarily recalled 489,437 units of Sodium Bicarbonate in 5% Dextrose and various strengths of Norepinephrine injections because they lack assurance of sterility. These products were distributed nationwide in the USA to hospitals, clinics, and healthcare facilities. While no incidents or injuries have been reported to date, products intended to be sterile that are compromised can cause serious health complications.

Risk

Injectable medications that are not sterile pose a significant risk of causing systemic infections. If a patient receives a contaminated injection, it could lead to life-threatening conditions or long-term injury.

What You Should Do

This recall affects SterRx brand Sodium Bicarbonate in 5% Dextrose (150 mEq per 1,000 mL) and Norepinephrine in 0.9% Sodium Chloride (4 mg, 8 mg, 16 mg, and 32 mg strengths) packaged in single-dose IV bags.
Check the NDC number and the lot number printed on the IV bag label or the shipping case to see if your product is included in this recall. See the Affected Products section below for the full list of affected codes.
Stop using the recalled product. Contact SterRx, LLC or your medical supply distributor to arrange for the return of any remaining inventory.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions regarding this recall.

Your Remedy Options

Other Action

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL)by SterRx

Variants: 1,000 mL Single Dose bag, 6 units per case

Lot Numbers (86):

489344 (Exp 25-Jul-23)

489352 (Exp 26-Jul-23)

489361 (Exp 27-Jul-23)

489387 (Exp 28-Jul-23)

491647 (Exp 28-Jul-23)

492181 (Exp 29-Jul-23)

492199 (Exp 2-Aug-23)

492201 (Exp 2-Aug-23)

492210 (Exp 3-Aug-23)

492228 (Exp 3-Aug-23)

492236 (Exp 4-Aug-23)

492244 (Exp 4-Aug-23)

492261 (Exp 5-Aug-23)

492279 (Exp 8-Aug-23)

492287 (Exp 8-Aug-23)

492295 (Exp 9-Aug-23)

492308 (Exp 9-Aug-23)

492957 (Exp 19-Sep-23)

492965 (Exp 19-Sep-23)

492973 (Exp 20-Sep-23)

492981 (Exp 20-Sep-23)

494194 (Exp 21-Sep-23)

494207 (Exp 21-Sep-23)

494215 (Exp 22-Sep-23)

494223 (Exp 22-Sep-23)

494231 (Exp 23-Sep-23)

495200 (Exp 23-Sep-23)

495218 (Exp 26-Sep-23)

495453 (Exp 26-Sep-23)

495470 (Exp 27-Sep-23)

495488 (Exp 27-Sep-23)

495496 (Exp 28-Sep-23)

495509 (Exp 28-Sep-23)

495517 (Exp 29-Sep-23)

495525 (Exp 29-Sep-23)

495533 (Exp 30-Sep-23)

495699 (Exp 3-Oct-23)

495701 (Exp 3-Oct-23)

495710 (Exp 4-Oct-23)

495728 (Exp 4-Oct-23)

496106 (Exp 15-Nov-23)

497491 (Exp 15-Nov-23)

497504 (Exp 16-Nov-23)

497512 (Exp 16-Nov-23)

497521 (Exp 22-Nov-23)

497539 (Exp 22-Nov-23)

497547 (Exp 23-Nov-23)

497555 (Exp 23-Nov-23)

497563 (Exp 24-Nov-23)

497571 (Exp 29-Nov-23)

NDC:

70324-326-01

Sterile IV bags manufactured in Plattsburgh, NY.

Product: Norepinephrine 4 mg per 250 mL (16 mcg per mL) in 0.9% Sodium Chlorideby SterRx

Variants: 250 mL Single Dose bag, 12 units per case

Lot Numbers:

490062 (Exp 22-Jul-23)

490151 (Exp 28-Jul-23)

490732 (Exp 6-Aug-23)

491591 (Exp 17-Aug-23)

491604 (Exp 18-Aug-23)

494418 (Exp 16-Nov-23)

494426 (Exp 17-Nov-23)

494434 (Exp 23-Nov-23)

496755 (Exp 25-Nov-23)

497424 (Exp 3-Dec-23)

497432 (Exp 4-Dec-23)

497441 (Exp 7-Dec-23)

497459 (Exp 7-Dec-23)

498005 (Exp 10-Dec-23)

499075 (Exp 22-Jan-24)

499083 (Exp 25-Jan-24)

499091 (Exp 25-Jan-24)

499391 (Exp 26-Jan-24)

501964 (Exp 23-Mar-24)

501972 (Exp 28-Mar-24)

501981 (Exp 30-Mar-24)

501999 (Exp 6-Apr-24)

502001 (Exp 7-Apr-24)

NDC:

70324-552-01

Rx only.

Product: Norepinephrine 8 mg per 250 mL (32 mcg per mL) in 0.9% Sodium Chlorideby SterRx

Variants: 250 mL Single Dose bag, 12 units per case

Lot Numbers:

490071 (Exp 30-Jul-23)

490089 (Exp 4-Aug-23)

490118 (Exp 5-Aug-23)

490126 (Exp 5-Aug-23)

490169 (Exp 10-Aug-23)

491276 (Exp 11-Aug-23)

491284 (Exp 12-Aug-23)

491612 (Exp 18-Aug-23)

497467 (Exp 8-Dec-23)

497475 (Exp 9-Dec-23)

499104 (Exp 18-Jan-24)

499112 (Exp 19-Jan-24)

499121 (Exp 20-Jan-24)

499278 (Exp 20-Jan-24)

499358 (Exp 21-Jan-24)

502019 (Exp 24-Mar-24)

502027 (Exp 29-Mar-24)

502035 (Exp 5-Apr-24)

503513 (Exp 18-Apr-24)

504217 (Exp 20-Apr-24)

NDC:

70324-577-01

Rx only.

Product: Norepinephrine 16 mg per 250 mL (64 mcg per mL) in 0.9% Sodium Chlorideby SterRx

Variants: 250 mL Single Dose bag, 12 units per case

Lot Numbers:

490097 (Exp 3-Aug-23)

490142 (Exp 10-Aug-23)

491292 (Exp 13-Aug-23)

494442 (Exp 26-Nov-23)

496763 (Exp 30-Nov-23)

496771 (Exp 1-Dec-23)

497408 (Exp 2-Dec-23)

497416 (Exp 3-Dec-23)

499438 (Exp 28-Jan-24)

501032 (Exp 8-Feb-24)

501059 (Exp 15-Feb-24)

502043 (Exp 28-Mar-24)

502051 (Exp 31-Mar-24)

503505 (Exp 4-Apr-24)

504031 (Exp 7-Apr-24)

504250 (Exp 19-Apr-24)

NDC:

70324-602-01

Rx only.

Product: Norepinephrine 32 mg per 250 mL (128 mcg per mL) in 0.9% Sodium Chlorideby SterRx

Variants: 250 mL Single Dose bag, 12 units per case

Lot Numbers:

490100 (Exp 27-Jul-23)

NDC:

70324-702-01

Rx only.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92657

Status: Resolved

Manufacturer: SterRx, LLC

Sold By: Hospitals; Clinics; Healthcare Facilities

Manufactured In: United States

Units Affected: 5 products (137,304 bags; 132,299 bags; 125,598 bags; 92,148 bags; 2,088 bags)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects SterRx brand Sodium Bicarbonate in 5% Dextrose (150 mEq per 1,000 mL) and Norepinephrine in 0.9% Sodium Chloride (4 mg, 8 mg, 16 mg, and 32 mg strengths) packaged in single-dose IV bags.

Check the NDC number and the lot number printed on the IV bag label or the shipping case to see if your product is included in this recall. See the Affected Products section below for the full list of affected codes.

Stop using the recalled product. Contact SterRx, LLC or your medical supply distributor to arrange for the return of any remaining inventory.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions regarding this recall.

Affected Products

Product: Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL)by SterRx

Variants: 1,000 mL Single Dose bag, 6 units per case

Lot Numbers (86):

489344 (Exp 25-Jul-23)

489352 (Exp 26-Jul-23)

489361 (Exp 27-Jul-23)

489387 (Exp 28-Jul-23)

491647 (Exp 28-Jul-23)

492181 (Exp 29-Jul-23)

492199 (Exp 2-Aug-23)

492201 (Exp 2-Aug-23)

492210 (Exp 3-Aug-23)

492228 (Exp 3-Aug-23)

492236 (Exp 4-Aug-23)

492244 (Exp 4-Aug-23)

492261 (Exp 5-Aug-23)

492279 (Exp 8-Aug-23)

492287 (Exp 8-Aug-23)

492295 (Exp 9-Aug-23)

492308 (Exp 9-Aug-23)

492957 (Exp 19-Sep-23)

492965 (Exp 19-Sep-23)

492973 (Exp 20-Sep-23)

492981 (Exp 20-Sep-23)

494194 (Exp 21-Sep-23)

494207 (Exp 21-Sep-23)

494215 (Exp 22-Sep-23)

494223 (Exp 22-Sep-23)

494231 (Exp 23-Sep-23)

495200 (Exp 23-Sep-23)

495218 (Exp 26-Sep-23)

495453 (Exp 26-Sep-23)

495470 (Exp 27-Sep-23)

495488 (Exp 27-Sep-23)

495496 (Exp 28-Sep-23)

495509 (Exp 28-Sep-23)

495517 (Exp 29-Sep-23)

495525 (Exp 29-Sep-23)

495533 (Exp 30-Sep-23)

495699 (Exp 3-Oct-23)

495701 (Exp 3-Oct-23)

495710 (Exp 4-Oct-23)

495728 (Exp 4-Oct-23)

496106 (Exp 15-Nov-23)

497491 (Exp 15-Nov-23)

497504 (Exp 16-Nov-23)

497512 (Exp 16-Nov-23)

497521 (Exp 22-Nov-23)

497539 (Exp 22-Nov-23)

497547 (Exp 23-Nov-23)

497555 (Exp 23-Nov-23)

497563 (Exp 24-Nov-23)

497571 (Exp 29-Nov-23)

NDC:

70324-326-01

Sterile IV bags manufactured in Plattsburgh, NY.

Product: Norepinephrine 4 mg per 250 mL (16 mcg per mL) in 0.9% Sodium Chlorideby SterRx

Variants: 250 mL Single Dose bag, 12 units per case

Lot Numbers:

490062 (Exp 22-Jul-23)

490151 (Exp 28-Jul-23)

490732 (Exp 6-Aug-23)

491591 (Exp 17-Aug-23)

491604 (Exp 18-Aug-23)

494418 (Exp 16-Nov-23)

494426 (Exp 17-Nov-23)

494434 (Exp 23-Nov-23)

496755 (Exp 25-Nov-23)

497424 (Exp 3-Dec-23)

497432 (Exp 4-Dec-23)

497441 (Exp 7-Dec-23)

497459 (Exp 7-Dec-23)

498005 (Exp 10-Dec-23)

499075 (Exp 22-Jan-24)

499083 (Exp 25-Jan-24)

499091 (Exp 25-Jan-24)

499391 (Exp 26-Jan-24)

501964 (Exp 23-Mar-24)

501972 (Exp 28-Mar-24)

501981 (Exp 30-Mar-24)

501999 (Exp 6-Apr-24)

502001 (Exp 7-Apr-24)

NDC:

70324-552-01

Rx only.

Product: Norepinephrine 8 mg per 250 mL (32 mcg per mL) in 0.9% Sodium Chlorideby SterRx

Variants: 250 mL Single Dose bag, 12 units per case

Lot Numbers:

490071 (Exp 30-Jul-23)

490089 (Exp 4-Aug-23)

490118 (Exp 5-Aug-23)

490126 (Exp 5-Aug-23)

490169 (Exp 10-Aug-23)

491276 (Exp 11-Aug-23)

491284 (Exp 12-Aug-23)

491612 (Exp 18-Aug-23)

497467 (Exp 8-Dec-23)

497475 (Exp 9-Dec-23)

499104 (Exp 18-Jan-24)

499112 (Exp 19-Jan-24)

499121 (Exp 20-Jan-24)

499278 (Exp 20-Jan-24)

499358 (Exp 21-Jan-24)

502019 (Exp 24-Mar-24)

502027 (Exp 29-Mar-24)

502035 (Exp 5-Apr-24)

503513 (Exp 18-Apr-24)

504217 (Exp 20-Apr-24)

NDC:

70324-577-01

Rx only.

Product: Norepinephrine 16 mg per 250 mL (64 mcg per mL) in 0.9% Sodium Chlorideby SterRx

Variants: 250 mL Single Dose bag, 12 units per case

Lot Numbers:

490097 (Exp 3-Aug-23)

490142 (Exp 10-Aug-23)

491292 (Exp 13-Aug-23)

494442 (Exp 26-Nov-23)

496763 (Exp 30-Nov-23)

496771 (Exp 1-Dec-23)

497408 (Exp 2-Dec-23)

497416 (Exp 3-Dec-23)

499438 (Exp 28-Jan-24)

501032 (Exp 8-Feb-24)

501059 (Exp 15-Feb-24)

502043 (Exp 28-Mar-24)

502051 (Exp 31-Mar-24)

503505 (Exp 4-Apr-24)

504031 (Exp 7-Apr-24)

504250 (Exp 19-Apr-24)

NDC:

70324-602-01

Rx only.

Product: Norepinephrine 32 mg per 250 mL (128 mcg per mL) in 0.9% Sodium Chlorideby SterRx

Variants: 250 mL Single Dose bag, 12 units per case

Lot Numbers:

490100 (Exp 27-Jul-23)

NDC:

70324-702-01

Rx only.