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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

QuVa Pharma, Inc.: Norepinephrine Injection Recalled for Using Incorrect Mixing Solution

Agency Publication Date: December 11, 2018
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Summary

QuVa Pharma is recalling 168 bags of Norepinephrine (8 mg in 250 mL), a prescription medication used to treat low blood pressure. The product was mistakenly mixed using 5% Dextrose instead of the required 0.9% Sodium Chloride solution. This error was discovered by the company and affects products distributed in California with an expiration date of January 6, 2019. Because this is a compounded medication used in clinical settings, patients should be aware of the potential for unintended reactions to the dextrose solution.

Risk

The use of 5% Dextrose instead of 0.9% Sodium Chloride as the base solution (excipient) can cause unintended blood sugar elevations or may be incompatible with other medications being administered to a patient simultaneously. While the risk is categorized as low, using the incorrect mixing solution could lead to adverse health consequences depending on a patient's underlying medical condition.

What You Should Do

  1. Check your medical supplies for Norepinephrine 8 mg (32 mcg/mL) in 250 mL bags with Product Code 70092-9035-05.
  2. Verify if the medication is from Lot #10016014 with an expiration date of 01/06/2019.
  3. Immediately stop using any bags identified as being from the affected lot.
  4. Contact your healthcare provider or pharmacist immediately for guidance if you or a patient have been administered this medication.
  5. Return any unused bags from Lot #10016014 to the pharmacy or place of purchase for a refund and further instructions.
  6. Contact QuVa Pharma at their Sugar Land, Texas facility if you have questions regarding the return process.
  7. For additional questions or to report a problem, 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

Contact healthcare provider and return for refund

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

Affected Products

Product: Norepinephrine 8 mg (32 mcg/mL) added to 0.9% Sodium Chloride Injection 250 mL Bag
Model:
70092-9035-05
D-0295-2019
Lot Numbers:
10016014 (Exp. 01/06/2019)
Date Ranges: 01/06/2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81644
Status: Resolved
Manufacturer: QuVa Pharma, Inc.
Sold By: QuVa Pharma
Manufactured In: United States
Units Affected: 168 bags
Distributed To: California
Agency Last Updated: December 12, 2018

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.