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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

IntegraDose Fentanyl Citrate CADD Injection Recalled for Leaking Bags

Agency Publication Date: April 3, 2024
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Summary

IntegraDose Compounding Services LLC is recalling 187 cassettes of Fentanyl Citrate (2,500 mcg/50mL) CADD for Injection because of leaking bags that could compromise the product's sterility. This recall affects products labeled as Lot 20231020FEN-1 with an expiration date of April 17, 2024. If you are using this medication in a clinical or home setting, you should immediately check your supplies for the affected lot number and contact the manufacturer or your distributor for instructions on returning the product.

Risk

Leaking bags create a breach in the sterile barrier, potentially allowing bacteria or other contaminants to enter the medication. Injecting a non-sterile drug can lead to serious, life-threatening infections or other severe medical complications.

What You Should Do

  1. This recall involves fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, packaged in medication cassettes (NDC 71139-6030-1).
  2. Identify the affected product by checking for Lot number 20231020FEN-1 with an expiration date of 04/17/2024 printed on the cassette label.
  3. Stop using the recalled product immediately.
  4. Contact IntegraDose Compounding Services LLC or your medical distributor to arrange for the return of any remaining affected units.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions or need to report a problem.

Your Remedy Options

๐Ÿ“‹Other Action

Return to manufacturer/distributor

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: fentaNYL Citrate 2,500 mcg/50mL in Sterile Water (50 mL)
Variants: CADD for Injection
Lot Numbers:
20231020FEN-1 (Exp 04/17/2024)
NDC:
71139-6030-1

Quantity affected: 187 cassettes; Distributed nationwide.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94275
Status: Active
Manufacturer: IntegraDose Compounding Services LLC
Sold By: Hospitals; Infusion Centers; Medical Wholesalers
Manufactured In: United States
Units Affected: 187 cassettes
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.