FDA recall F-1479-2019

Product

Viralox, UPC 8 63784 00015 0. Immune Balancing Ploypeptide Oral Spray. 5.0 fl. oz. (150 ml) Oral Spray.

Reason for recall

The recall is being conducted as a result of elevated APC levels. Through additional testing, it was determined that the organism is Stenotrophomonas maltophilia.

Distribution

Nationwide and Switzerland. No military/govt/VA consignees.

Key facts

Status

Terminated

Initiation date

2019-05-15

Report date

2019-06-26

Termination date

2019-12-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Phoenix, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=F-1479-2019