Dragonfly Botanicals Full spectrum Breathe Deep 1000mg/oz Dietary Supplement, sold in…

Green Water, LLC recalled this product and the FDA reported the enforcement action on 26 February 2020 as Class II. The recall was initiated by the firm. The products contain Coltsfoot, which is not to be used internally.

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

Dragonfly Botanicals Full spectrum Breathe Deep 1000mg/oz Dietary Supplement, sold in 0.5 oz, 1 oz, 2 oz, and 4 oz amber glass bottles with dropper.

Reason for recall

The products contain Coltsfoot, which is not to be used internally.

Recalling firm

Green Water, LLC

Firm location

Conifer, Colorado, United States

Classification

Class II

Status

Terminated

Recall number

F-0708-2020

Quantity

268 units

Distribution

CO, GA, IA, KY physical locations. Nationwide via internet.

Initiated

24 October 2019

Reported by FDA

26 February 2020

Terminated

7 June 2021

Firm notified by

Other

Product codes

Lot numbers 1093 and 1108 Exp: 01/2020-10/2024

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. All 3 of them are listed on this page.
• The recall ran for 19 months, from 24 October 2019 to termination on 7 June 2021. 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 distribution pattern names 3 states, and the FDA published the enforcement report 4 months after the firm began the recall.
• Recalls of a dietary supplement run a median of 15 months, so this one was longer 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.

Named in the distribution pattern: Colorado, Georgia, Iowa. Those pages count recalls by where the RECALLING FIRM sits, which is a different question from where this product went.

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

Every product in this recall

The FDA opened 3 enforcement records for this one recall, one per product code. This page carries all of them; the 2 below each have their own page with that product’s lot codes and distribution, and search engines are pointed here for the recall as a whole.

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 Green Water, LLC

The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 9 other records name this firm.

All 10 records for Green Water, LLC

All 2020 recalls · All FDA food recall data