FDA recall D-1215-2016

Medaus, Inc. · Class II · drug

Product

METHYL B12 1000MCG/ML/PYRIDOXINE 100MG W/PRES. (BENZALKONIUM 0.01%), In a) 1ML 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-1215-2016