IT Custom Compound Baclofen 2000 mcg/ml recalled over sterility concerns
- Recall date
- December 24, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Amerita Specialty Infusion Services recalls IT Custom Compound (BC) Baclofen 2000 mcg/ml, Clonidine 2 mcg/ml 40 ml PF syringe, FOR INTRATHECAL USE ONLY, Rx Only, C…
- Recall number
- D-0570-2016
- FDA classification
- Class II
- Brand / firm
- Amerita Specialty Infusion Services
- Sold / distributed
- AZ only. No foreign distribution.
Why it was recalled
Lack of Assurance of Sterility
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
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