Livia One Organic Probiotic Nasal Spray; 1 oz. (30 ml) UPC: 0 30915 10719 8 Suggested…

Livia Global recalled this product and the FDA reported the enforcement action on 22 December 2021 as Class II. The recall was initiated by the firm. Probiotic products contaminated with Pseudomonas aeruginosa .

The record

Every field below is published by the FDA in the openFDA food enforcement database. Check the FDA notice before acting on any recall: this page is a reading of the public record, not a substitute for it.

Product

Livia One Organic Probiotic Nasal Spray; 1 oz. (30 ml) UPC: 0 30915 10719 8 Suggested use: Adult - 102 pumps in each nostril as needed 1-3 times per day; Children 4-12 years : 1/4-1/2 pump in each nostril as needed - 103 times daily as needed. Children 3 and under: It is always advised to consult with a pediatrician or healthcare provided before use.. Ingredients: Proprietary probiotic blend in an enzyme enriched substrate. Made from water and a proprietary blend of three organic grasses Bottles and Distributed by: Livia Global Inc., Visalia, CA.

UPC

030915107198

Reason for recall

Probiotic products contaminated with Pseudomonas aeruginosa .

Recalling firm

Livia Global

Firm location

Visalia, California, United States

Classification

Class II

Status

Terminated

Recall number

F-0359-2022

Quantity

1130 x 1 oz. bottles

Distribution

xx

Initiated

1 December 2021

Reported by FDA

22 December 2021

Terminated

29 April 2022

Firm notified by

Press Release

Product codes

Lot #001005-1, BB 04/2023; Lot # 010620-1, BB 08/2023

Reading this record

Five things about this record are not in the record itself, and each one changes how it should be read.

• Class II means the FDA judged a remote probability of serious harm, or a probability of temporary or medically reversible harm. The class is assigned by an agency health hazard evaluation under 21 CFR 7.41, not by the firm.
• The firm started this recall itself. Most FDA food recalls are voluntary, and a recall is a food safety plan working rather than failing. The circumstances in which the agency asks for one instead are set out in 21 CFR 7.45.
• This is one of 3 records covering the same recall event. The FDA opens one enforcement record per product code, so a recall of a product line appears here many times. Counting these records as 3 separate recalls, which almost every published figure does, overstates it by a factor of 3. Every product code in this event is listed together on the record that covers the whole recall, which is the page a search engine is pointed to for all 3 of them.
• The recall ran for 5 months, from 1 December 2021 to termination on 29 April 2022. Termination means the agency judged that all reasonable effort had been made, under 21 CFR 7.55, and it says nothing about whether product remained in circulation.
• The FDA published the enforcement report 3 weeks after the firm began the recall.
• Recalls of a dietary supplement run a median of 15 months, so this one was shorter than usual for its category. Dietary supplements are regulated under their own good manufacturing practice rule, 21 CFR part 111, and they are the only food category where the dominant recall reason is an ingredient that was never declared because it is a pharmaceutical.

Filed under dietary supplements. A product can sit in more than one.

Other dietary supplements recalls

These are the closest records in the corpus: the same kind of food. Unlike the firm’s own records below, they come from different companies, which is what makes them a pattern rather than a history.

Other records from Livia Global

The FDA opens one enforcement record per product code, so several of these are frequently one recall event.

All 3 records for Livia Global

All 2021 recalls · All FDA food recall data