APS BioGroup, Inc

Recall #F-1479-2019 · Initiated 2019-05-15

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.

Quantity affected

7,132 Total Units

Distribution

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

Lot / code info

Manufactured April 21, 2019. Lot 9068-2, Item # 4044, Bulk # UL-7, Exp. Date 04/2021; Lot 9068-3, Item # 4691, Bulk # UL-7, Exp. Date 04/2021; Lot 9068-4, Item # 4181, Bulk # UL-7, Exp. Date 04/2021; Lot 9068-5, Item # 00064, Bulk # UL-7, Exp. Date 04/2021; Lot 9068-6, Item # 00064, Bulk # UL-7, Exp. Date 04/2021

Voluntary / mandated

Voluntary: Firm initiated

Initial notification

Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Terminated

2019-12-27