Iowa Select Herbs LLC, Milk Thistle Seed (Carduus marianus), www.iowaselectherbs.com…

Iowa Select Herbs LLC recalled this product and the FDA reported the enforcement action on 11 May 2016 as Class III. The recall was mandated. Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.

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

Iowa Select Herbs LLC, Milk Thistle Seed (Carduus marianus), www.iowaselectherbs.com, (a) 4 fl. Oz., (b) 16 fl. Oz., (c) 32 fl. Oz., Cedar Rapids, IA 52402

Reason for recall

Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.

Recalling firm

Iowa Select Herbs LLC

Firm location

Cedar Rapids, Iowa, United States

Classification

Class III

Status

Terminated

Recall number

F-1196-2016

Quantity

(a) 2 bottles, (d) 97 bottles (c) 1 bottle

Distribution

The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.

Initiated

11 September 2015

Reported by FDA

11 May 2016

Terminated

27 February 2017

Firm notified by

Press Release

Product codes

Lot - 32358, Expires - 10/2019; Lot - 32964, Expires - 10/2019; Lot - 631H42200122, Expires - 10/2019;

Reading this record

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

• Class III means the FDA judged that the product was unlikely to cause harm but violated FDA labelling or manufacturing regulation. The class is assigned by an agency health hazard evaluation under 21 CFR 7.41, not by the firm.
• This recall was not recorded as firm-initiated. The circumstances in which the FDA requests a recall are set out in 21 CFR 7.45.
• This is one of 104 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 104 separate recalls, which almost every published figure does, overstates it by a factor of 104. 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 104 of them.
• The recall ran for 18 months, from 11 September 2015 to termination on 27 February 2017. 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 8 states, and the FDA published the enforcement report 8 months after the firm began the recall.
• Recalls of milk or a dairy product run a median of 7 months, so this one was longer than usual for its category. Dairy recalls split between pathogen contamination in products that skipped or under-ran pasteurisation and undeclared milk in products that should never have contained it, which is the same allergen viewed from two directions.

Named in the distribution pattern: Florida, Georgia, Iowa, Michigan, Missouri, Montana, New York, South Carolina. Those pages count recalls by where the RECALLING FIRM sits, which is a different question from where this product went.

What this recall was for

Filed under milk and dairy and fresh produce. A product can sit in more than one.

Other milk and dairy 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 Iowa Select Herbs LLC

The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 103 other records name this firm.

All 104 records for Iowa Select Herbs LLC

All 2016 recalls · All FDA food recall data