FDA recall D-0255-2019

Silver Star Brands · Class II · drug

Product

Healthful Naturals DizziFree Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-204-02

Reason for recall

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

Distribution

Nationwide USA

Key facts

Status
Terminated
Initiation date
2018-10-03
Report date
2018-11-14
Termination date
2019-08-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
Oshkosh, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0255-2019