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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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High RiskFDA Drug
Medications & Supplements/Prescription Drugs

QuVa Pharma, Inc.: Oxytocin IV Bags Recalled for Subpotency and Missing Medication

Agency Publication Date: June 11, 2020
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Summary

QuVa Pharma, Inc. is recalling 648 bags of Oxytocin (30 Units in 500 mL of 0.9% Sodium Chloride Injection) because the product was found to be subpotent and, in some cases, did not contain the drug at all. This prescription medication is used to induce or improve labor contractions during childbirth or to control postpartum bleeding. If you are a healthcare provider or patient who has used this specific lot, please be aware that the lack of active medication may result in ineffective treatment. Consumers should contact their healthcare provider or pharmacist immediately regarding this recall.

Risk

The product is subpotent or missing the active ingredient entirely, which means it will not provide the intended therapeutic effect. In a clinical setting, failure of oxytocin to perform as expected can lead to delayed labor or uncontrolled bleeding after delivery, potentially requiring emergency medical intervention.

What You Should Do

  1. Identify if you have the affected product by checking the label for 'oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride Injection for IV Use' with NDC 70092-1068-07.
  2. Check the packaging for Lot Number 30010515 to confirm if your specific unit is part of the recall.
  3. Stop using any product identified from this lot immediately and quarantine the remaining inventory.
  4. Contact your healthcare provider or pharmacist for guidance if you have recently been administered this medication or have it in your possession.
  5. Return any unused product to the pharmacy or place of purchase for a refund and contact QuVa Pharma at 888-339-0874 for further instructions.
  6. For additional information 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

๐Ÿ’ฐFull Refund
How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund and contact the manufacturer at 888-339-0874.

Affected Products

Product: oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride Injection for IV Use
Model:
NDC 70092-1068-07
Recall #: D-1302-2020
Lot Numbers:
30010515

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85773
Status: Resolved
Manufacturer: QuVa Pharma, Inc.
Sold By: Hospitals; Healthcare facilities
Manufactured In: United States
Units Affected: 648 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 ยท 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.