FDA recall D-1224-2016
Medaus, Inc. · Class II · drug
Product
M.I.C 25/50/50 W/PRES. (BENZYL ETOH 2%) METHIONINE 25MG;INOSITOL 50MG;CHOLINE CHL 50/MG/ML, In a) 5ML Vials and b) 10ML 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-1224-2016