IT Custom Compound (BC) Baclofen 2000 mcg/ml, Clonidine 2 mcg/ml 40 ml PF syringe, FOR INTRATHECA...
FDA Recall #D-0570-2016 — Class II — December 24, 2015
Product Description
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
Reason for Recall
Lack of Assurance of Sterility
Recalling Firm
Amerita Specialty Infusion Services — Prescott, AZ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
1 syringe
Distribution
AZ only. No foreign distribution.
Code Information
Lot # 112621/E; Exp. 10/15
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated