CLASS II Drug recall · Reported 27 Jan 2016 · FDA Enforcement Report
Baclofen 1 mg/ml in NS syringe, For Intrathecal Use Only recalled
Amerita Specialty Infusion Services is recalling Baclofen 1 mg/ml in NS syringe, For Intrathecal Use Only, distributed in Arizona. The recall was initiated on 24 Dec 2015 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0569-2016
- FDA event ID
- 72967
- Recalling firm
- Amerita Specialty Infusion Services, Prescott, AZ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Dec 2015
- FDA classified
- 15 Jan 2016
- Reported
- 27 Jan 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Drug class
- Compounded Drugs
Timeline
| 24 Dec 2015 | Recall initiated by company | |
| 15 Jan 2016 | Classified by FDA | +22 days |
| 27 Jan 2016 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Baclofen 1 mg/ml in 40 ml NS syringe, FOR INTRATHECAL USE ONLY, Rx Only, Compounded by Amerita, Inc., Prescott, AZ 86305-1614
Where it was distributed
AZ only. No foreign distribution.
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lot # 112621/E; Exp 12/15
Where was it sold?
AZ only. No foreign distribution.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 72967This product is part of a recall event; the main page for the event is IT Custom Compound (BC) Baclofen 2000 mcg/ml recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | IT Custom Compound (BC) Baclofen 2000 mcg/ml recalled | Amerita Specialty Infusion Services | Sterility | AZ |
More recalls from Amerita Specialty Infusion Services
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | IT Custom Compound (BC) Baclofen 2000 mcg/ml recalled | Amerita Specialty Infusion Services | Sterility | AZ |
Other Baclofen recalls
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Baclofen Tablets USP, 10 mg recalled by Golden State Medical SupplyBaclofen | Golden State Medical Supply | Other | Nationwide |
| Drug | CLASS II | Baclofen 2000MCG/ML INJ in syringe Assurance Infusion (713) recalled | Assurance Infusion | Sterility | Nationwide |
| Drug | CLASS II | Baclofen and Clonidine HCL and Morphine Sulfate recalled | Coast Quality Pharmacy | Packaging Defects | Nationwide |
| Drug | CLASS II | Gablofen (baclofen injection), 50 mcg/mL, Single Use Syringe recalledGablofen | Piramal Critical Care | Potency & Assay | Nationwide |
| Drug | CLASS II | Baclofen 5000 mcg/ml, vol recalled by Hartley Medical Center | Hartley Medical Center Pharmacy | Sterility | Nationwide |