FDA recall D-0623-2018

Elroselabs Inc. · Class II · drug

Product

Conzerol (antipoxin) H2O2 Gel, Hydrogen Peroxide Gel 3%, 1.5 oz. tube, OTC, Manufactured for Elrose Labs, Inc., Sanford, FL

Reason for recall

cGMP Deviations

Distribution

Nationwide.

Key facts

Status
Terminated
Initiation date
2018-03-28
Report date
2018-04-18
Termination date
2020-12-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Sanford, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0623-2018