BulkSupplements.com Recalls Glucosamine Sulfate Potassium for Undeclared Shellfish
Hard Eight Nutrition LLC is recalling two lots of Glucosamine Sulfate Potassium because the product labels failed to declare shellfish as an ingredient.
The agency’s classification
FDA (Food): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves allergen mislabeling on a common allergen (shellfish), which corresponds to a severity score of 3 (High) per the rubric.
Plain-English summary
Hard Eight Nutrition LLC is voluntarily recalling two lots of BulkSupplements.com Glucosamine Sulfate Potassium. The recall involves 100-gram, 250-gram, 500-gram, and 1-kilogram stand-up zipper pouch bags. The specific lots affected are 121D1214 (expiration date 12/13/18) and 121E0629 (expiration date 06/28/19).
The recall was initiated after an FDA inspection found that the product labels did not declare shellfish as an ingredient, although shellfish is properly declared on the company's website. Shellfish is a major food allergen, and the failure to list it on the physical label poses a risk to consumers with shellfish allergies.
Approximately 2,100 units were distributed worldwide through the company's website and Amazon. The product was also distributed to Australia, Austria, Canada, the Czech Republic, Denmark, Finland, France, Germany, Iceland, the Isle of Man, Italy, Japan, Liechtenstein, Luxembourg, the Netherlands, New Zealand, Norway, South Africa, Sweden, Switzerland, the Philippines, and the United Kingdom. Consumers should check their inventory for these specific lot numbers and stop using the product if they have a shellfish allergy.
The recalled product
- Product
- BulkSupplements.com Glucosamine Sulfate Potassium; 100 grams, 250 grams, 500 grams, 1 kilogram; Stand up zipper pouch bags. Directions: As a dietary supplement, take 1000 mg (scant 1/4 tsp) up to three time daily, or as directed by a physician. Distributed exclusively…
- Manufacturer
- Hard Eight Nutrition LLC
- Category
- Food — Dietary Supplement
- Affected units
- 2,100
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 (4)
- Lot: 121D1214
- Exp: 12/13/18
- Lot: 121E0629
- Exp: 06/28/19.
Distribution
Distribution scope not specified by the agency.
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