The Recall Desk
SevereFDA (Drugs)·D-0473-2017·Announced 2017-02-22

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.

What this means for you

Illness, injury, or structural failure has been reported. 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
Hazard
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

Distributed in 2 states:

Related recalls

Same hazard · undeclared ingredient

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