Dark Chocolate Pretzel Balls, 15 lbs.

GKI Foods, LLC recalled this product and the FDA reported the enforcement action on 29 November 2017 as Class II. The recall was initiated by the firm. GKI Foods of Brighton, Michigan is voluntarily recalling multiple dark chocolate products because they may contain an undeclared milk allergen.

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

Dark Chocolate Pretzel Balls, 15 lbs.

Reason for recall

GKI Foods of Brighton, Michigan is voluntarily recalling multiple dark chocolate products because they may contain an undeclared milk allergen.

Recalling firm

GKI Foods, LLC

Firm location

Brighton, Michigan, United States

Classification

Class II

Status

Terminated

Recall number

F-0328-2018

Quantity

N/A

Distribution

Domestic: MI, IN, IL, FL, TX, CA., NV, OR, NH, NY, NJ, VA, WI, KY, DE, PA, CT, PR, OH, RI, IA,

Initiated

27 October 2017

Reported by FDA

29 November 2017

Terminated

9 July 2018

Firm notified by

Press Release

Product codes

Retail Dark Chocolate Pretzel Balls manufactured between 01/14/16 to 10/24/17; and Bulk Dark Chocolate Pretzel Balls manufactured between 01/14/16 to 09/05/2017; Lots: Lot# 08316 Lot# 20116B Lot# 27316B Lot# 27316 Lot# 06017 Lot# 22717 Lot# 27717 Lot# 03916 Lot# 08316 Lot# 08316 Lot# 14416 Lot# 14416 Lot# 18816 Lot# 19416 Lot# 21416 Lot# 23616 Lot# 32716 Lot# 34916 Lot# 06017 Lot# 07317 Lot# 08117 Lot# 09317 Lot# 10217 Lot# 19917 Lot# 21217 Lot# 24817 Lot# 27416

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 21 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 21 separate recalls, which almost every published figure does, overstates it by a factor of 21. 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 21 of them.
• The recall ran for 8 months, from 27 October 2017 to termination on 9 July 2018. 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 20 states, and the FDA published the enforcement report 5 weeks after the firm began the recall.
• Recalls of a snack or confectionery product run a median of 7 months, so this one was about typical for its category. Snacks and confectionery recall for allergens more than for anything else, because a chocolate or a coated snack passes through shared equipment carrying milk, soy and nuts, and the label is the only control between them and the consumer.

Named in the distribution pattern: Indiana, Illinois, Florida, Texas, California, Nevada, Oregon, New Hampshire, New York, New Jersey, Virginia, Wisconsin, Kentucky, Delaware, Pennsylvania, Connecticut, Puerto Rico, Ohio, Rhode Island, Iowa. 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

The allergens named in this record: milk.

Filed under snacks and confectionery. A product can sit in more than one.

Other snacks and confectionery 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 GKI Foods, LLC

The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 21 other records name this firm.

All 22 records for GKI Foods, LLC

All 2017 recalls · All FDA food recall data