SLIMFIT X capsules recalled for undeclared sibutramine and desmethylsibutramine
Jersey Shore Supplements, LLC is recalling SLIMFIT X capsules because they contain undeclared sibutramine and desmethylsibutramine and were marketed without an approved NDA/ANDA.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.
Plain-English summary
Jersey Shore Supplements, LLC is recalling 150 bottles of SLIMFIT X capsules, packaged in 60-count bottles. The recall covers all lots and all expiration dates. The product was distributed in New Jersey and Maryland.
The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) and contains undeclared sibutramine and desmethylsibutramine.
Consumers who have purchased this product should stop using it and contact the recalling firm for further instructions.
The recalled product
- Product
- SLIMFIT X capsules, packaged in a 60-cont bottle
- Manufacturer
- Jersey Shore Supplements, LLC
- Category
- Drug — Dietary Supplement
- Affected units
- 150
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 and all expiration dates.
Distribution
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