Good Herbs, Inc., FEMALE HEALTH, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The…

Good Herbs, Inc. recalled this product and the FDA reported the enforcement action on 5 November 2014 as Class II. The recall was initiated by the firm. Products not manufactured under GMP's

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

Good Herbs, Inc., FEMALE HEALTH, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works

Reason for recall

Products not manufactured under GMP's

Recalling firm

Good Herbs, Inc.

Firm location

Troy, Michigan, United States

Classification

Class II

Status

Terminated

Recall number

F-0198-2015

Quantity

Approximately 1099 total units for all products

Distribution

National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported

Initiated

25 March 2014

Reported by FDA

5 November 2014

Terminated

3 February 2016

Firm notified by

Letter

Product codes

All lots distributed on or after October 17, 2013.

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 117 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 117 separate recalls, which almost every published figure does, overstates it by a factor of 117. 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 117 of them.
• The recall ran for 22 months, from 25 March 2014 to termination on 3 February 2016. 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 15 states, and the FDA published the enforcement report 7 months after the firm began the recall.
• Recalls of fresh produce run a median of 7 months, so this one was longer than usual for its category. Fresh produce is the category where contamination arrives before the facility does: irrigation water, soil amendments and field workers are the routes, and nothing downstream of the farm is a kill step for a product eaten raw.

Named in the distribution pattern: California, Connecticut, Florida, Indiana, Maine, Michigan, Missouri, Mississippi, North Carolina, New Hampshire, New York, Ohio, Oregon, Rhode Island, Texas. Those pages count recalls by where the RECALLING FIRM sits, which is a different question from where this product went.

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

Other fresh produce 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 Good Herbs, Inc.

The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 352 other records name this firm.

All 353 records for Good Herbs, Inc.

All 2014 recalls · All FDA food recall data