Healthmaxx Global Inc. recalled this product and the FDA reported the enforcement action on 2 October 2013 as Class III. The recall was initiated by the firm. In response to a FDA inspection, the firm initiated this voluntary recall of various dietary supplements due to the following problems of mislabeling: 1) product named on the label is not actual product contained; 2)ingredients listed are not actual ingredients contained.
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
MAX Brand Organic OPC31 Grapeseed Extract, 200 Count Capsules. Product labeling reads in part:"MAX Organic OPC31 Grapeseed Extract***NEW WITH BLUEBERRY***Dietary Supplement 200 CAPSULES***Manufactured in FDA Approved Facility for:HealthMax Products Inc. Altadena, CA 91001***".
Reason for recall
In response to a FDA inspection, the firm initiated this voluntary recall of various dietary supplements due to the following problems of mislabeling: 1) product named on the label is not actual product contained; 2)ingredients listed are not actual ingredients contained.
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.
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 28 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 28 separate recalls, which almost every published figure does, overstates it by a factor of 28. 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 28 of them.
The recall ran for 17 months, from 10 June 2013 to termination on 14 November 2014. 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 3 states, and the FDA published the enforcement report 4 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, Maryland, New York. Those pages count recalls by where the RECALLING FIRM sits, which is a different question from where this product went.
An undeclared allergen recall means a food contained one of the major allergens and the label did not say so, either because the wrong label was applied or because an ingredient carried an allergen nobody traced.
A preventive controls plan covers an undeclared allergen 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 117.135(c)(2)
Food allergen controls: the written preventive controls that keep an allergen out of a food it does not belong in, and that get the allergens present onto the label.
21 CFR 101.4
Ingredient declaration: every ingredient listed by its common name, in descending order of predominance, on the label of a packaged food.
21 CFR 117 subpart G
Supply-chain programme: the approval and verification a receiving facility runs on a supplier when the hazard is controlled before the ingredient arrives.
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.
Undeclared Soy. Finished product ingredients statement declares Worcestershire sauce but does not declare sub-ingredients Soy Flavoring and Soy Lecithin.
Undeclared Soy. The firm received complaints of sausage in the burritos. Upon review the firm discovered the sausage contains soy which is not listed on the label.
In response to a FDA inspection, the firm initiated this voluntary recall of various dietary supplements due to the following problems of mislabeling: 1) product named on the label is not actual product contained; 2)ingredients listed are not actual ingredients contained.
In response to a FDA inspection, the firm initiated this voluntary recall of various dietary supplements due to the following problems of mislabeling: 1) product named on the label is not actual product contained; 2)ingredients listed are not actual ingredients contained.
In response to a FDA inspection, the firm initiated this voluntary recall of various dietary supplements due to the following problems of mislabeling: 1) product named on the label is not actual product contained; 2)ingredients listed are not actual ingredients contained.
In response to a FDA inspection, the firm initiated this voluntary recall of various dietary supplements due to the following problems of mislabeling: 1) product named on the label is not actual product contained; 2)ingredients listed are not actual ingredients contained.
In response to a FDA inspection, the firm initiated this voluntary recall of various dietary supplements due to the following problems of mislabeling: 1) product named on the label is not actual product contained; 2)ingredients listed are not actual ingredients contained.
In response to a FDA inspection, the firm initiated this voluntary recall of various dietary supplements due to the following problems of mislabeling: 1) product named on the label is not actual product contained; 2)ingredients listed are not actual ingredients contained.
In response to a FDA inspection, the firm initiated this voluntary recall of various dietary supplements due to the following problems of mislabeling: 1) product named on the label is not actual product contained; 2)ingredients listed are not actual ingredients contained.
In response to a FDA inspection, the firm initiated this voluntary recall of various dietary supplements due to the following problems of mislabeling: 1) product named on the label is not actual product contained; 2)ingredients listed are not actual ingredients contained.
In response to a FDA inspection, the firm initiated this voluntary recall of various dietary supplements due to the following problems of mislabeling: 1) product named on the label is not actual product contained; 2)ingredients listed are not actual ingredients contained.
In response to a FDA inspection, the firm initiated this voluntary recall of various dietary supplements due to the following problems of mislabeling: 1) product named on the label is not actual product contained; 2)ingredients listed are not actual ingredients contained.
21 CFR 117.135(c)(2) 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.
