Medications & Supplements/Prescription Drugs

QuVa Pharma, Inc.: Norepinephrine 4 mg in 5% Dextrose Recalled for Missing Active Ingredient

Agency Publication Date: September 18, 2018

Summary

QuVa Pharma, Inc. is recalling 528 bags of Norepinephrine 4 mg (16 mcg/mL) added to 5% Dextrose (250 mL bags) because the product may not actually contain any of the active medication. This subpotent drug could fail to provide the necessary treatment to patients in critical hospital settings. This prescription-only medication was distributed nationwide to hospitals between August and September 2018. If you are a hospital administrator or healthcare provider, you should immediately check your inventory for the affected lot and contact the manufacturer to return any remaining supply.

Risk

Patients receiving this product may not receive the intended dose of norepinephrine, a critical medication used to increase blood pressure in emergency situations. The lack of active ingredient could lead to a failure to stabilize a patient's blood pressure, potentially resulting in life-threatening clinical consequences.

What You Should Do

Immediately check your hospital or clinic inventory for Norepinephrine 4 mg (16 mcg/mL) in 5% Dextrose 250 mL Bags with UPC 70092103417.
Verify if your product matches Lot Number 30000271 with an expiration date of 10/1/18.
Stop using and quarantine any affected bags from Lot 30000271 immediately to ensure they are not administered to patients.
Contact your healthcare provider or pharmacist for guidance regarding any concerns about medication previously administered.
Return any unused product from the affected lot to the place of purchase for a refund and contact QuVa Pharma, Inc. at their Sugar Land, Texas facility for further return instructions.
For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Drug recall refund and consultation

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Norepinephrine 4 mg (16 mcg/mL) added to 5% Dextrose (250 mL Bag)

UPC Codes:

70092103417

Lot Numbers:

30000271 (Exp 10/1/18)

Date Ranges: Expiration date 10/1/18

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80980

Status: Resolved

Manufacturer: QuVa Pharma, Inc.

Sold By: Hospitals

Manufactured In: United States

Units Affected: 528 bags

Distributed To: Nationwide

Agency Last Updated: October 1, 2018

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

Risk

What You Should Do

Immediately check your hospital or clinic inventory for Norepinephrine 4 mg (16 mcg/mL) in 5% Dextrose 250 mL Bags with UPC 70092103417.

Verify if your product matches Lot Number 30000271 with an expiration date of 10/1/18.

Stop using and quarantine any affected bags from Lot 30000271 immediately to ensure they are not administered to patients.

Contact your healthcare provider or pharmacist for guidance regarding any concerns about medication previously administered.

Return any unused product from the affected lot to the place of purchase for a refund and contact QuVa Pharma, Inc. at their Sugar Land, Texas facility for further return instructions.

For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.