Drug product
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
D-0570-2016
Product summary
- Event
- Event 72967
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 syringe
- Official record key
drug-enforcement:D-0570-2016
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot # 112621/E; Exp. 10/15
Distribution pattern: AZ only. No foreign distribution.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility