Intrathecal Compounding Specialist: Sterile Drug Preparations Risk Infection
Intrathecal Compounding Specialist recalls sterile drug preparations made from Hydromorphone Base Solution between Oct 2017 and Nov 2017 due to lack of sterility assurance. Affected items may cause infection if used.
Recall notice
Lack of sterility assurance.
Contact the company
What happened, in plain English
Intrathecal Compounding Specialist recalls all sterile drug preparations made from Hydromorphone Base Solution between October 16, 2017 and November 17, 2017. Using these preparations could lead to infection because they lack proper sterility assurance. Read more at govinfonow.com/recall/41035-intrathecal-compounding-specialist-sterile-drug-preparations-risk-infection.
Source Summary by GovInfoNow · govinfonow.com/recall/41035-intrathecal-compounding-specialist-sterile-drug-preparations-risk-infection · Updated October 7, 2026 · FDA enforcement record: FDA #D-0321-2018
Cite this page
“Intrathecal Compounding Specialist: Sterile Drug Preparations Risk Infection.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/41035-intrathecal-compounding-specialist-sterile-drug-preparations-risk-infection. Based on FDA recall #D-0321-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0321-2018%22&limit=1).
Why it’s dangerous
The drug preparations lack sterility assurance, meaning they could be contaminated with bacteria or other pathogens. If used in medical procedures, this contamination could lead to infections in patients.
Who’s affected
Healthcare professionals who compounded these drugs between October 16, 2017 and November 17, 2017 are likely affected. Patients receiving these preparations may be at risk of infection.
How to tell if you have this one
Check if the drug was compounded by Intrathecal Compounding Specialist in Scott, LA between October 16, 2017 and November 17, 2017. Look for lot numbers with expiration dates between November 15, 2017 and December 16, 2017.
- Brand
Intrathecal Compounding Specialist- Category
Drug
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0320-2018 | All sterile drug preparations remaining within expiry prepared from Fentanyl Citrate Base Solution dispensed between October 16, 2017 and November 17, 2017 Compounded by Intrathecal Compounding Specialists, Scott, LA 70583.; All lots remaining within expiry (BUDs between November 15, 2017 and December 16, 2017) | Unknown. |
| D-0321-2018 | All sterile drug preparations remaining within expiry prepared from Hydromorphone Base Solution dispensed between October 16, 2017 and November 17, 2017, Compounded by Intrathecal Compounding Specialists, Scott, LA 70583.; All lots remaining within expiry (BUDs between November 15, 2017 and December 16, 2017). | Unknown |
| D-0322-2018 | All sterile drug preparations remaining within expiry prepared from Morphine Sulfate PF Base Solution dispensed between October 16, 2017 and November 17, 2017, Compounded by Intrathecal Compounding Specialists, Scott, LA 70583.; All lots remaining within expiry (BUD between November 15, 2017 and December 16, 2017). | Unknown |
| D-0323-2018 | All sterile drug preparations remaining within expiry prepared from Sufentanil Citrate Base Solution dispensed between October 16, 2017 and November 17, 2017, Compounded by Intrathecal Compounding Specialists, Scott, LA 70583.; All lots remaining within expiry (BUDs between November 15, 2017 and December 16, 2017). | Unknown |
What to do — step by step
Check Expiry Date
Verify the expiration date (BUD) is between November 15, 2017 and December 16, 2017.
Contact Manufacturer
Reach out to Intrathecal Compounding Specialist for more information about affected products.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 17 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0321-2018 (November 30, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0321-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.