Amerita Recalls Intrathecal Baclofen/Clonidine Syringes Due to Sterility Risk
Amerita Specialty Infusion Services recalls specific lots of intrathecal baclofen and clonidine syringes due to a lack of assurance of sterility.
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Lack of Assurance of Sterility
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What happened, in plain English
Amerita Specialty Infusion Services is recalling one lot of IT Custom Compound (BC) Baclofen 2000 mcg/ml, Clonidine 2 mcg/ml in a 40 ml PF syringe intended for intrathecal use. The recall was issued because the manufacturer could not assure that the product remained sterile during production or distribution. This poses a risk of infection if the medication is administered. Read more at govinfonow.com/recall/43304-amerita-recalls-intrathecal-baclofen-clonidine-syringes-due-to-sterility-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/43304-amerita-recalls-intrathecal-baclofen-clonidine-syringes-due-to-sterility-risk · Updated October 11, 2026 · FDA enforcement record: FDA #D-0570-2016
Cite this page
“Amerita Recalls Intrathecal Baclofen/Clonidine Syringes Due to Sterility Risk.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43304-amerita-recalls-intrathecal-baclofen-clonidine-syringes-due-to-sterility-risk. Based on FDA recall #D-0570-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0570-2016%22&limit=1).
Why it’s dangerous
The product lacks assurance of sterility, meaning harmful microorganisms may be present in the syringe. Administering a non-sterile medication directly into the intrathecal space (around the spinal cord) can lead to severe infections such as meningitis or abscesses.
Who’s affected
Patients in Arizona who received this specific compounded intrathecal medication from Amerita Specialty Infusion Services are affected. Healthcare providers and patients using this prescription drug for pain management or spasticity control are at risk of serious infection.
How to tell if you have this one
Check if you have a 40 ml PF syringe labeled 'IT Custom Compound (BC) Baclofen 2000 mcg/ml, Clonidine 2 mcg/ml' for intrathecal use only. Verify the lot number is 112621/E and the expiration date is 10/15. The product was distributed only within Arizona.
- Brand
Amerita- Category
Drug
All 2 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
AZ only. No foreign distribution.
| Recall number | Product, codes & lots |
|---|---|
| D-0569-2016 | Baclofen 1 mg/ml in 40 ml NS syringe, FOR INTRATHECAL USE ONLY, Rx Only, Compounded by Amerita, Inc., Prescott, AZ 86305-1614; Lot # 112621/E; Exp 12/15 |
| D-0570-2016 | IT Custom Compound (BC) Baclofen 2000 mcg/ml, Clonidine 2 mcg/ml 40 ml PF syringe, FOR INTRATHECAL USE ONLY, Rx Only, Compounded by Amerita, Inc., Prescott, AZ 86305-1614; Lot # 112621/E; Exp. 10/15 |
What to do — step by step
Stop using the syringe
Do not administer the medication if you have the recalled lot number.
Contact your healthcare provider
Reach out to your doctor or pharmacist immediately for guidance on alternative treatment options.
Where it went and when
Where it was distributed
Distributed in Arizona.
FDA distribution: “AZ only. No foreign distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona.
Recall timeline
FDA terminated this recall 48 days 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-0570-2016 (December 24, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0570-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 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.