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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

OurPharma Fentanyl Citrate Injection Solutions Recalled for Underfilled Cassettes

Agency Publication Date: December 9, 2022
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Summary

OurPharma LLC has recalled 691 cassettes of FentaNYL Citrate (2.5 mg/50 mL) Injection Solution because some cassettes may be underfilled. This clinical pain medication, which is repackaged by the firm, may provide a lower dose than intended if the cassette is not full. No incidents or injuries have been reported to date, but the firm is voluntarily recalling these specific lots distributed in Missouri to ensure patient safety.

Risk

An underfilled cassette can result in a patient receiving less than the prescribed dose of fentanyl. This could lead to inadequate pain management or potential withdrawal symptoms for patients in a clinical or hospital environment.

What You Should Do

  1. The recalled products are 50 ml cassettes of FentaNYL Citrate 2.5 mg/50 mL (50mcg/ml) Injection Solution, which are preservative-free and labeled as Rx Only (NDC 73013-001-01).
  2. Identify affected products by checking for lot numbers 100122060007 (Exp. 12/17/2022), 100122060008 (Exp. 12/18/2022), or 100122070002 (Exp. 01/09/2023).
  3. Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.
  4. Contact OurPharma LLC directly at 1-833-290-2654 for specific instructions on how to return the affected cassettes.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 if you have additional questions regarding this safety alert.

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 Injection Solution (2.5 mg/50 mL)
Variants: 50mcg/ml, Preservative Free, Single Use 50 ml Cassette, Rx Only
Lot Numbers:
100122060007 (Exp. 12/17/2022)
100122060008 (Exp. 12/18/2022)
100122070002 (Exp. 01/09/2023)
NDC:
73013-001-01

Repackaged by OurPharma, LLC.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91229
Status: Resolved
Manufacturer: OurPharma LLC
Sold By: OurPharma LLC
Manufactured In: United States
Units Affected: 691 cassettes
Distributed To: Missouri

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.