FDA recall D-1174-2016

Medaus, Inc. · Class II · drug

Product

B-COMPLEX W/CYANO B12 W/PRES., (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG, B6-2MG, CYANO B12 1MG/ML, In a) 2ML Vials, b) 5MLVials, 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-1174-2016