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Recall Observatory FDA recall evidence

Food product

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

F-1479-2019

May 15, 2019

Class II

Product summary

Firm
APS BioGroup, Inc
Event
Event 82900
Status
Terminated
Classification
Class II
Quantity
7,132 Total Units
Official record key
food-enforcement:F-1479-2019

Official wording

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

Code information: 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

Distribution pattern: Nationwide and Switzerland. No military/govt/VA consignees.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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