The Recall Desk
Agency classClass IIOur severity:SevereFDA (Food)·F-1480-2019·Announced 2019-06-26

APS BioGroup Recalls DPS Throat Spray Due to Bacterial Contamination

APS BioGroup is recalling DPS Throat Spray because testing found elevated levels of Stenotrophomonas maltophilia bacteria.

The agency’s classification

FDA (Food): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls with potential for significant injury or hospitalization (implied by the presence of a pathogenic organism) are rated as Severe.

Plain-English summary

APS BioGroup, Inc. is recalling 7,132 units of DPS Throat Spray, UPC 8 55602 00021 3. Colostrum Immune Concentrate, Net 150 ml. The recall is being conducted as a result of elevated APC (aerobic plate count) levels. Through additional testing, it was determined that the organism present is Stenotrophomonas maltophilia.

The affected product was manufactured on April 21, 2019, and includes Lots 9068-2, 9068-3, 9068-4, 9068-5, and 9068-6, all with an expiration date of 04/2021. The product was distributed nationwide and in Switzerland. The recall is classified as FDA Class II.

Consumers should stop using the product and return it to the place of purchase for a refund or contact the recalling firm for instructions.

The recalled product

Product
DPS Throat Spray, UPC 8 55602 00021 3. Colostrum Immune Concentrate. Net 150 ml
Manufacturer
APS BioGroup, Inc
Category
Food — Dietary Supplement
Hazard
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 →

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