Recalls / Class I

Class ID-1142-2016

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

Jenesis Capsules, 350 mg, 60-count bottles, Manufactured for Timeless Solutions 1810 E. Sahara Ave #100 Las Vegas, Nevada 89104

Affected lot / code info: All lots

Why it was recalled

Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.

Recalling firm

Firm: Bee Extremely Amazed LLC
Notification channel: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Type: Voluntary: Firm initiated
Address: 85205 Sportsmans Club Rd, N/A, Jewett, Ohio 43986-9794

Distribution

Quantity: 79 bottles
Distribution pattern: Nationwide

Timeline

Recall initiated: 2015-12-15
FDA classified: 2016-07-06
Posted by FDA: 2016-07-13
Terminated: 2020-04-23
Status: Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1142-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.