Fit Firm and Fabulous Recalls Ultimate Herbal Slimcap Capsules
Fit Firm and Fabulous is recalling Ultimate Herbal Slimcap Capsules because they contain undeclared sibutramine, a controlled substance removed from the U.S. market for safety reasons.
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
Fit Firm and Fabulous is recalling Ultimate Herbal Slimcap Capsules, 350 mg, 30-count bottles. The product is labeled as Part 1 of 3 and carries the UPC 5 42423 25422 1. The recall involves 3,000 bottles with lot numbers ranging from 05/02/2015 to 05/01/2017.
The FDA determined that the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Although marketed as a dietary supplement, the product was found to be tainted with undeclared sibutramine. Sibutramine is a previously approved controlled substance that was removed from the U.S. market in October 2010 for safety reasons. The presence of this undeclared substance renders the product an unapproved drug.
The product was distributed nationwide in the U.S.A. via the company's website. Consumers who have purchased this product should stop using it and contact the recalling firm for further instructions.
The recalled product
- Product
- Ultimate Herbal Slimcap Capsules, 350 mg*, 30-count bottles, labeled Part 1 of 3, fit firm & fabulous, UPC 5 42423 25422 1.
- Manufacturer
- Fit Firm and Fabulous
- Category
- Drug — Dietary Supplement
- Affected units
- 3,000
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)
- Lot #: 05/02/2015 to 05/01/2017
Distribution
Distributed nationwide across the United States.
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