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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

Intrathecal Compounding Specialist, LLC: Various Compounded Sterile Pain Medications Recalled for Sterility Concerns

Agency Publication Date: February 4, 2018
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Summary

Intrathecal Compounding Specialist, LLC is recalling several compounded sterile drug preparations, including Fentanyl Citrate, Hydromorphone, Morphine Sulfate PF, and Sufentanil Citrate. The recall affects all units dispensed between October 16, 2017, and November 17, 2017, due to a lack of sterility assurance. Without guaranteed sterility, these injectable medications could contain microorganisms that lead to serious infections. Consumers should contact their healthcare provider or pharmacist immediately if they received these medications from the Scott, Louisiana facility during the specified period.

Risk

A lack of sterility assurance in medications injected into the spinal canal (intrathecal) poses a significant risk of life-threatening infections, such as meningitis. While no specific injuries were mentioned in the recall notice, the potential for systemic harm is high whenever the sterile barrier of a compounded drug is compromised.

What You Should Do

  1. Check your medication packaging or medical records for sterile preparations of Fentanyl Citrate, Hydromorphone, Morphine Sulfate PF, or Sufentanil Citrate compounded by Intrathecal Compounding Specialists in Scott, Louisiana.
  2. Verify if the medication was dispensed between October 16, 2017, and November 17, 2017, or has a 'Beyond Use Date' (expiration) between November 15, 2017, and December 16, 2017.
  3. Contact your healthcare provider or pharmacist immediately to discuss your treatment and determine if you have been affected.
  4. Return any unused portions of the recalled medication to the pharmacy where it was dispensed to receive a refund.
  5. Contact the manufacturer, Intrathecal Compounding Specialist, LLC, at their Scott, LA facility for additional instructions on returning the product.
  6. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for further information regarding this recall.

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare provider consultation and pharmacy refund.

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

Affected Products

Product: Fentanyl Citrate Base Solution (Sterile Drug Preparation)
Model:
Recall #: D-0320-2018
Lot Numbers:
All lots with BUDs between Nov 15, 2017 and Dec 16, 2017
Date Ranges: Dispensed between October 16, 2017 and November 17, 2017
Product: Hydromorphone Base Solution (Sterile Drug Preparation)
Model:
Recall #: D-0321-2018
Lot Numbers:
All lots with BUDs between Nov 15, 2017 and Dec 16, 2017
Date Ranges: Dispensed between October 16, 2017 and November 17, 2017
Product: Morphine Sulfate PF Base Solution (Sterile Drug Preparation)
Model:
Recall #: D-0322-2018
Lot Numbers:
All lots with BUDs between Nov 15, 2017 and Dec 16, 2017
Date Ranges: Dispensed between October 16, 2017 and November 17, 2017
Product: Sufentanil Citrate Base Solution (Sterile Drug Preparation)
Model:
Recall #: D-0323-2018
Lot Numbers:
All lots with BUDs between Nov 15, 2017 and Dec 16, 2017
Date Ranges: Dispensed between October 16, 2017 and November 17, 2017

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78669
Status: Resolved
Manufacturer: Intrathecal Compounding Specialist, LLC
Sold By: Intrathecal Compounding Specialist, LLC
Manufactured In: United States
Units Affected: 4 products (Unknown.; Unknown; Unknown; Unknown)
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.

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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.