Iowa Select Herbs Recalls Atractylodes for Misbranding and Adulteration
Iowa Select Herbs LLC is recalling Atractylodes (Atractylodes macrocephala) under a consent decree because the product is misbranded, an unapproved new drug, and an adulterated dietary supplement.
The agency’s classification
FDA (Food): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric indicates is typically a score of 1 or 2. A score of 2 is assigned due to the legal mandate (consent decree) and the specific regulatory violations (misbranding, unapproved new drug, adulteration), which are more significant than simple cosmetic or packaging errors.
Plain-English summary
Iowa Select Herbs LLC is recalling 10 bottles of Atractylodes (Atractylodes macrocephala), 4 fl. Oz., manufactured in Cedar Rapids, IA. The product, identified by Lot 45811 with an expiration date of 05/2017, was distributed to retail stores in California, Florida, Georgia, Iowa, Michigan, Missouri, Montana, New York, and South Carolina, as well as to consumers nationwide and internationally in Denmark, Canada, the UK, Australia, and Serbia.
The recall is being conducted pursuant to a consent decree for injunctive relief. The firm was ordered to recall all products because they are misbranded, unapproved new drugs, and adulterated dietary supplements. The U.S. Food and Drug Administration has classified this recall as Class III.
Consumers who have purchased this product should stop using it and contact the recalling firm for further instructions or a refund.
The recalled product
- Product
- Iowa Select Herbs LLC,Atractylodes (Atractylodes macrocephala), www.iowaselectherbs.com, 4 fl. Oz., Cedar Rapids, IA 52402
- Manufacturer
- Iowa Select Herbs LLC
- Category
- Food — Dietary Supplement
- Affected units
- 10
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot - 45811
- Expires - 05/2017
Distribution
Part of a larger recall action
This product is one of 104 recalled by Iowa Select Herbs LLC under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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