Herbal Doctor Remedies Recalls Dermamycin Capsules for Unapproved New Drug Status
Herbal Doctor Remedies is recalling Dermamycin 500mg capsules because the products are misbranded as unapproved new drugs.
The agency’s classification
FDA (Drugs): 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 is classified as FDA Class II, and the hazard involves unapproved new drugs, which fits the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Herbal Doctor Remedies is recalling Dermamycin, 500mg capsules, 90-count bottles. The recall was initiated because the products have been found to be misbranded as unapproved new drugs, which constitutes a Current Good Manufacturing Practice (CGMP) deviation.
The affected products were sold online within the United States and internationally to Australia, Canada, Israel, Italy, Japan, Norway, and the United Kingdom. All lots within expiry are included in this recall.
Consumers who have purchased these products should stop using them and contact Herbal Doctor Remedies at 1(800) 600-0808 for further instructions.
The recalled product
- Product
- Dermamycin, 500mg Capsules, 90-count bottles, 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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