FDA recall D-1222-2016

Medaus, Inc. · Class II · drug

Product

M.I.C B-COMPLEX PREMIX W/HYDROXY B12 W/PRES. (BENZALKONIUM 0.01%) HYDROXY B12 1MG; B1 0.833MG; B2 0.083MG; B3 0.833MG, B5 0.083MG, B6 0.083MG, CYANO B12 1.66MCG, METHIONINE 0.208MG, INOSITOL 0.416MG, CHOLINE CL 1.66MG/ML, 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-1222-2016