Super Herbs 350 mg capsules recalled for undeclared active ingredients
Super Herbs 350 mg capsules are being recalled because they contain undeclared sibutramine, desmethylsibutramine, and/or phenolphthalein.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Super Herbs is recalling 9 bottles of SUPER HERBS 350 mg, 30 capsules per bottle. The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
The recall is due to the presence of undeclared sibutramine, desmethylsibutramine (an active metabolite of sibutramine), and/or phenolphthalein. These ingredients were not declared on the product label.
The recall affects 9 consignees, with only 9 bottles distributed. Consumers should stop using the product and contact the recalling firm for instructions.
The recalled product
- Product
- SUPER HERBS 350 mg, 30 capsules per bottle.
- Manufacturer
- Super Herbs
- Category
- Drug — Dietary Supplement
- Affected units
- 9
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
Distribution
Distribution scope not specified by the agency.
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