FDA recall D-1245-2016
Medaus, Inc. · Class II · drug
Product
TESTOSTERONE CYP 50 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials, b) 2ML Vials, c) 3ML Vials, d) 4ML Vials, and e) 5ML Vials, MEDAUS PHARMACY
Reason for recall
Lack of Assurance of Sterility
Distribution
U.S. Nationwide, Japan, and New Zealand.
Key facts
- Status
- Terminated
- Initiation date
- 2016-05-13
- Report date
- 2016-07-20
- Termination date
- 2017-06-16
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Birmingham, AL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1245-2016