Recall Radar

APS BioGroup recalls Immulox and 3 more: label issue

June 26, 2019 · APS BioGroup Class II

Class IIFDA’s middle class: use of the product may cause temporary or medically reversible adverse health consequences, or the chance of serious harm is remote.
Reason for the recallThe recall is being conducted as a result of elevated APC levels. Through additional testing, it was determined that the organism is Stenotrophomonas maltophilia.

Find the official FDA enforcement report

Recall at a glance

Recalling company
APS BioGroup
Location
Phoenix, AZ
Reported by FDA
June 26, 2019
Recall started
May 15, 2019
Risk class
Class II
Status (latest data we have)
Terminated
Type
Voluntary: Firm initiated
Category
Supplements and infant formula
Reason type
Labeling and quality

Is my product affected?

Compare your product’s name, size and lot or date codes with the list below. A recall usually covers only specific codes.

  • Immulox, UPC 1 82863 000064 6. Immune Balance Polypeptide Supplement with Naturally Occuring Bioactive Peptides. 5.07 oz (150 ml)
    Quantity: 7,132 Total Units
    Codes: 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
  • DPS Throat Spray, UPC 8 55602 00021 3. Colostrum Immune Concentrate. Net 150 ml
    Quantity: 7,132 Total Units
    Codes: 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
  • Viralox, UPC 8 63784 00015 0. Immune Balancing Ploypeptide Oral Spray. 5.0 fl. oz. (150 ml) Oral Spray.
    Quantity: 7,132 Total Units
    Codes: 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
  • Immuno PRP Spray, UPC 8 12527 01176 2. Colostrum Polypeptides. 5 fl oz (140 mL)
    Quantity: 7,132 Total Units
    Codes: 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

Where it was distributed

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

What to do

If you have this product, check the codes above. FDA recall notices often tell consumers to stop eating the product and to return it or throw it away. Follow the company’s instructions and the official FDA information, and if you are unsure, do not eat it. If someone becomes ill after eating a recalled food, contact a healthcare professional. See FDA’s recalls and safety alerts for company announcements.

Frequently asked questions

What was recalled?

APS BioGroup recalled 4 products, including Immulox, UPC 1 82863 000064 6. Immune Balance Polypeptide Supplement with Naturally Occuring Bioactive Peptides. 5.07 oz (150 ml).

Why was it recalled?

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

What does Class II mean?

FDA’s middle class: use of the product may cause temporary or medically reversible adverse health consequences, or the chance of serious harm is remote.

Where was it sold or shipped?

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

What should I do if I have this product?

Compare the product name, size and lot or date codes with the details on this page. FDA recall notices often tell you to stop eating the product and to return it or throw it away. Follow the company’s instructions and the official FDA information. If you are unsure, do not eat it.

Similar recalls in supplements and infant formula

Sources

Data provided by the U.S. Food and Drug Administration (FDA) through openFDA, shown as published and not validated by this site. This site is independent and is not affiliated with or endorsed by FDA. It covers FDA-regulated foods; meat, poultry and egg products are regulated by USDA. Do not rely on this site for medical decisions: for health concerns contact a healthcare professional, and always follow the official notice and the company’s instructions. Terms and disclaimer.