Recalls / Class I
Class ID-1207-2015
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
SLIM-K, 30 Capsules, barcode 160126417509, Distributed by: Bethel Inc.
- Affected lot / code info
- Lot # 140430; Exp.12/17
Why it was recalled
Marketed Without An Approved NDA/ANDA: Product was found to contain sibutramine, desmethylsibutramine and phenolphthalein based on FDA sampling and analysis.
Recalling firm
- Firm
- Bethel Nutritional Consulting, Inc
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 599 W 190th St Ste 1, N/A, New York, New York 10040-3577
Distribution
- Quantity
- UNKNOWN
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-12-19
- FDA classified
- 2015-07-06
- Posted by FDA
- 2015-07-15
- Terminated
- 2018-06-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1207-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.