FDA recall D-1214-2016
Medaus, Inc. · Class II · drug
Product
METHYL B12 1000MCG/ML W/PRES (BENZALKONIUM 0.01% IN NACL 0.9%, In a) 2ML Vials, b) 5ML Vials, and c) 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-1214-2016