FDA recall D-0569-2016
Amerita Specialty Infusion Services · Class II · drug
Product
Baclofen 1 mg/ml in 40 ml NS syringe, FOR INTRATHECAL USE ONLY, Rx Only, Compounded by Amerita, Inc., Prescott, AZ 86305-1614
Reason for recall
Lack of Assurance of Sterility
Distribution
AZ only. No foreign distribution.
Key facts
- Status
- Terminated
- Initiation date
- 2015-12-24
- Report date
- 2016-01-27
- Termination date
- 2016-02-10
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Prescott, AZ, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0569-2016