The Recall Desk
SevereFDA (Food)·F-1478-2019·Announced 2019-06-26

APS BioGroup Recalls Immuno PRP Spray Due to Bacterial Contamination

APS BioGroup is recalling Immuno PRP Spray because testing found elevated levels of Stenotrophomonas maltophilia. The product was distributed nationwide and in Switzerland.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are categorized as Severe (Score 4), particularly when involving significant contamination risks, even if specific hospitalization reports are not detailed in the provided text snippet.

Plain-English summary

APS BioGroup, Inc. is recalling Immuno PRP Spray, a colostrum polypeptide product, due to elevated levels of a specific bacterium. The recall involves 7,132 total units of the 5 fl oz (140 mL) spray, identified by UPC 8 12527 01176 2. The affected lots were manufactured on April 21, 2019, and have an expiration date of 04/2021.

The recall was initiated after additional testing determined that the organism causing the elevated APC (Atypical Pathogen Count) levels is Stenotrophomonas maltophilia. This bacterium is the specific cause for the product withdrawal.

The product was distributed nationwide in the United States and in Switzerland. There are no military, government, or VA consignees listed for this recall. Consumers should check their products for the specific lot numbers and expiration dates listed in the official recall notice and discontinue use if they match the recalled items.

The recalled product

Product
Immuno PRP Spray, UPC 8 12527 01176 2. Colostrum Polypeptides. 5 fl oz (140 mL)
Manufacturer
APS BioGroup, Inc
Affected units
7,132

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (12)

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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by APS BioGroup, Inc under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →