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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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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

SterRx Fentanyl Citrate IV Bags Recalled for Potential Lack of Sterility

Agency Publication Date: August 9, 2022
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Summary

SterRx, LLC is recalling 1,080 bags of Fentanyl Citrate in 0.9% Sodium Chloride IV bags due to a lack of assurance that the products are sterile. The recall includes Fentanyl Citrate 1 mg per 100 mL and 2.5 mg per 250 mL bags distributed to hospitals and healthcare facilities. No injuries or illnesses have been reported to date in connection with this issue.

Risk

Using a medication administered directly into the bloodstream that is not sterile can lead to life-threatening infections. Because Fentanyl Citrate is used for pain management in hospital settings, compromised sterility poses a significant risk to patients.

What You Should Do

  1. This recall affects SterRx Fentanyl Citrate in 0.9% Sodium Chloride IV bags (1 mg per 100 mL and 2.5 mg per 250 mL) with NDC numbers 70324-327-01 or 70324-327-02.
  2. Identify affected bags by checking for lot numbers CHI (with expiration date Dec 22, 2022) or CHL (with expiration date Dec 29, 2022) printed on the product labeling.
  3. Stop using the recalled product immediately.
  4. Contact the manufacturer, SterRx, LLC, or your distributor to arrange for the return of any remaining inventory.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Fentanyl Citrate in 0.9% Sodium Chloride (1 mg per 100 mL)
Variants: 1 mg per 100 mL, 10 mcg per mL, IV bag, Rx only
Lot Numbers:
CHI (Exp. Date Dec 22, 2022)
NDC:
70324-327-01

Quantity: 720 bags

Product: Fentanyl Citrate in 0.9% Sodium Chloride (2.5 mg per 250 mL)
Variants: 2.5 mg per 250 mL, 10 mcg per mL, IV bag, Rx only
Lot Numbers:
CHL (Exp. Date Dec 29, 2022)
NDC:
70324-327-02

Quantity: 360 bags

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90653
Status: Resolved
Manufacturer: SterRx, LLC
Sold By: Hospitals; Healthcare Facilities
Manufactured In: United States
Units Affected: 2 products (720 bags; 360 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.