Formula C&F packaged in 1 FL OZ (29mL) droppers. HoneyCombs Industries, 10671 6075 Road…

HoneyCombs Industries, LLC recalled this product and the FDA reported the enforcement action on 9 September 2015 as Class II. The recall was initiated by the firm. The powdered golden seal had a coliform count of 2000 cfu/g when the specifications stated less than 1000/cfy/g. There is 12mg of golden seal per dose.

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

Formula C&F packaged in 1 FL OZ (29mL) droppers. HoneyCombs Industries, 10671 6075 Road, Montrose, CO 81403.

Reason for recall

The powdered golden seal had a coliform count of 2000 cfu/g when the specifications stated less than 1000/cfy/g. There is 12mg of golden seal per dose.

Recalling firm

HoneyCombs Industries, LLC

Firm location

Montrose, Colorado, United States

Classification

Class II

Status

Terminated

Recall number

F-3068-2015

Quantity

161 bottles

Distribution

Distributed nationwide to CO, MO, FL, NC, IN, MI, TN, KS, WI, OH, NM, AZ, GA, NY, TX, PA, MD, and KY. No foreign/VA/govt/military.

Initiated

4 August 2015

Reported by FDA

9 September 2015

Terminated

2 March 2017

Firm notified by

Letter

Product codes

330

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 19 months, from 4 August 2015 to termination on 2 March 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 17 states, and the FDA published the enforcement report 5 weeks after the firm began the recall.
• The product description on this record names no food this site can classify, so it appears on no food-type page. That is a limit of the description rather than of the recall.

Named in the distribution pattern: Missouri, Florida, North Carolina, Indiana, Michigan, Tennessee, Kansas, Wisconsin, Ohio, New Mexico, Arizona, Georgia, New York, Texas, Pennsylvania, Maryland, Virginia. Those pages count recalls by where the RECALLING FIRM sits, which is a different question from where this product went.

Other records from HoneyCombs Industries, LLC

The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 6 other records name this firm.

All 7 records for HoneyCombs Industries, LLC

All 2015 recalls · All FDA food recall data