FDA recall D-0507-2020

Integrated Health Concepts Inc. dba Conversio Health · Class II · drug

Product

Formoterol 12mcg / Budesonide 0.5mg, 3.5ML Vial, For Inhalation Only, Shake Well, Conversio Health, San Luis Obispo, CA 93401.

Reason for recall

Lack of Processing Controls

Distribution

Nationwide in the U.S.

Key facts

Status
Terminated
Initiation date
2019-11-12
Report date
2019-11-27
Termination date
2020-05-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
San Luis Obispo, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0507-2020