Herbal Doctor Remedies Recalls DeTensin Ex for Unapproved New Drug Status
Herbal Doctor Remedies is recalling DeTensin Ex because the product is misbranded as an unapproved new drug. The recall covers all lots within expiry sold in the US and internationally.
What this means for you
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 II, which typically involves a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The source text does not report any specific illnesses or injuries, aligning with a moderate severity rating for a regulatory misbranding issue.
Plain-English summary
Herbal Doctor Remedies is recalling DeTensin Ex, a product distributed by the company in Alhambra, California. The recall was initiated because the products have been found to be misbranded as unapproved new drugs, which constitutes a deviation from Current Good Manufacturing Practices (CGMP).
The affected products are sold online within the United States and internationally to Australia, Canada, Israel, Italy, Japan, Norway, and the United Kingdom. The recall includes all lots within their expiry dates.
Consumers who have purchased DeTensin Ex should stop using the product and contact Herbal Doctor Remedies at 1(800) 600-0808 for further instructions.
The recalled product
- Product
- DeTensin Ex, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
- Manufacturer
- Herbal Doctor Remedies
- Category
- Drug — Unapproved New Drug
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 (1)
- All lots within expiry
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 70 recalled by Herbal Doctor Remedies under a single FDA (Drugs) 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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