SLIMFIT X capsules recalled over undeclared sibutramine
- Recall date
- December 9, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Jersey Shore Supplements, LLC recalls SLIMFIT X capsules, packaged in a 60-cont bottle
- Recall number
- D-0473-2017
- FDA classification
- Class I
- Brand / firm
- Jersey Shore Supplements, LLC
- Sold / distributed
- New Jersey and Maryland.
Why it was recalled
Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and desmethylsibutramine.
Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.
What was recalled
SLIMFIT X capsules, packaged in a 60-cont bottle
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