White plastic bottle with blue cap containing 90 capsules; Ashwagandha Extract; 450 mg…
NOW Foods recalled this product and the FDA reported the enforcement action on 31 July 2013 as Class II. The recall was initiated by the firm. It has been determined that this product contains an undeclared ingredient, licorice extract, which contains glycyrrhizin derived from licorice root.
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
White plastic bottle with blue cap containing 90 capsules; Ashwagandha Extract; 450 mg; CODE 4603; Manufactured by NOW FOODS; 395 S. Glen Ellyn Rd., Bloomingdale, IL 60108, USA
Reason for recall
It has been determined that this product contains an undeclared ingredient, licorice extract, which contains glycyrrhizin derived from licorice root.
UPC: 7 33739 04603 1; Product Code: 4603; Lot: 1599135; Best By: May 2015
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 record is the only one the FDA opened for its recall event, so it covers a single product code.
The recall ran for 2.7 years, from 3 July 2013 to termination on 28 March 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 FDA published the enforcement report 4 weeks after the firm began the recall.
Recalls of a dietary supplement run a median of 15 months, so this one was longer than usual for its category. Dietary supplements are regulated under their own good manufacturing practice rule, 21 CFR part 111, and they are the only food category where the dominant recall reason is an ingredient that was never declared because it is a pharmaceutical.
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.
Other dietary supplements 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.
NOW Health Group Inc. initiated a voluntary recall of NOW s Vitamin B-50 mg 100 Veg Caps product code 0420 because it is mislabeled as Vitamin B-50 mg 100 Veg Caps.
Product's supplement fact panel incorrectly states that the product contains 75 mg (milligrams) of Molybdenum, when it actually contains 75 mcg (micrograms).
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.
