D-0570-2016 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- January 27, 2016
- Initiation Date
- December 24, 2015
- Termination Date
- February 10, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 syringe
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
Distribution Pattern
AZ only. No foreign distribution.
Code Information
Lot # 112621/E; Exp. 10/15