Tova Industries Inc recalled this product and the FDA reported the enforcement action on 18 March 2020 as Class II. The recall was initiated by the firm. Downstream recall from supplier. Possible metal shavings in ingredient.
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
MJ Kellner brand Milk Replacer, Vegan, Soy Based, Item #80286, in 22.7g, metallic pouch, 300 pouches per case
Reason for recall
Downstream recall from supplier. Possible metal shavings in ingredient.
Products were distributed to the following states: AR, CA, IL, LA, MI, NE, NM, NY, VA, WI, and WY. Product was also distributed to the United Arab Emirates.
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 22 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 22 separate recalls, which almost every published figure does, overstates it by a factor of 22. All 22 of them are listed on this page.
The recall ran for 14 months, from 24 February 2020 to termination on 12 April 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 9 states, and the FDA published the enforcement report 3 weeks 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.
A foreign material recall means something that is not food was found in food: metal, plastic, glass, wood or insect matter, usually shed by equipment during processing.
A preventive controls plan covers foreign material under the clauses below. This is where the control belongs, not a finding against any firm named on this page: a recall record states a reason, and most of these recalls were initiated by the firm itself.
21 CFR 117.40
Equipment and utensils: plant equipment designed and maintained so it cannot contaminate food with lubricants, fuel, metal fragments or contaminated water.
21 CFR 117.80(c)
Manufacturing operations: the measures that protect food from contamination during processing, including the effective ones against metal and other extraneous material.
21 CFR 117.150
Corrective actions: what a facility does when a preventive control was not properly implemented, including identifying and correcting the problem and evaluating the food for safety.
Filed under milk and dairy. A product can sit in more than one.
Every product in this recall
The FDA opened 22 enforcement records for this one recall, one per product code. This page carries all of them; the 21 below each have their own page with that product’s lot codes and distribution, and search engines are pointed here for the recall as a whole.
Downstream recall from supplier. Possible metal shavings in ingredient.
Class II
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.
21 CFR 117.40 is the clause behind this recall, and it is one somebody has to produce evidence for at their next audit. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.
Recall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.
