Taspen s Organics, Breathe Easy Herbal Tincture, Net wt 1 ounce, 2 ounce, 4 ounce

Green Water, LLC recalled this product and the FDA reported the enforcement action on 28 August 2019 as Class II. The recall was initiated by the firm. recalling certain lots of Bedroom Bliss Herbal Tincture, Breathe Easy Herbal Tincture, Digest Ease Herbal Tincture, Happy Momma Herbal Tincture, Mojo Magic Herbal Tincture, Respiratory Tea, Mothers Milk Tea due to potential Salmonella contamination.

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

Taspen s Organics, Breathe Easy Herbal Tincture, Net wt 1 ounce, 2 ounce, 4 ounce

Reason for recall

recalling certain lots of Bedroom Bliss Herbal Tincture, Breathe Easy Herbal Tincture, Digest Ease Herbal Tincture, Happy Momma Herbal Tincture, Mojo Magic Herbal Tincture, Respiratory Tea, Mothers Milk Tea due to potential Salmonella contamination.

Recalling firm

Green Water, LLC

Firm location

Conifer, Colorado, United States

Classification

Class II

Status

Terminated

Recall number

F-2061-2019

Quantity

N/A

Distribution

Distributed nationwide. No foreign/VA/govt/military.

Initiated

30 July 2019

Reported by FDA

28 August 2019

Terminated

25 May 2021

Firm notified by

E-Mail

Product codes

1250, 1251

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 7 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 7 separate recalls, which almost every published figure does, overstates it by a factor of 7. 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 7 of them.
• The recall ran for 22 months, from 30 July 2019 to termination on 25 May 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 1 state, and the FDA published the enforcement report 4 weeks 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.

What this recall was for

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

Other dietary supplements recalls for the same reason

These are the closest records in the corpus: the same kind of food, recalled for a hazard this record also names. 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 2019 recalls · All FDA food recall data