FDA recall D-1198-2018

Beaumont Bio-med, Inc. · Class II · drug

Product

Colds & Flu Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7012-7

Reason for recall

CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.

Distribution

Nationwide in the USA

Key facts

Status
Terminated
Initiation date
2018-08-31
Report date
2018-09-26
Termination date
2022-09-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Waukon, IA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1198-2018