Immulox, UPC 1 82863 000064 6. Immune Balance Polypeptide Supplement with Naturally Occuring Bioactive Peptides. 5.07 oz (150 ml)

FDA recall notice · announced June 26, 2019 · Aps Biogroup

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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.

Notes

Distribution: Nationwide and Switzerland. No military/govt/VA consignees.
Lot/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
Quantity: 7,132 Total Units
Status: Terminated
Products in this recall event:
- DPS Throat Spray, UPC 8 55602 00021 3. Colostrum Immune Concentrate. Net 150 ml (F-1480-2019)
- Viralox, UPC 8 63784 00015 0. Immune Balancing Ploypeptide Oral Spray. 5.0 fl. oz. (150 ml) Oral Spray. (F-1479-2019)
- Immuno PRP Spray, UPC 8 12527 01176 2. Colostrum Polypeptides. 5 fl oz (140 mL) (F-1478-2019)
- Immulox, UPC 1 82863 000064 6. Immune Balance Polypeptide Supplement with Naturally Occuring Bioactive Peptides. 5.07 oz (150 ml) (F-1481-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.