FDA recall D-1171-2016

Medaus, Inc. · Class II · drug

Product

B-COMPLEX WITHOUT B12 W/PRES (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG, B6-2MG/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-1171-2016