Jenesis Capsules, 350 mg, 60-count bottles, Manufactured for Timeless Solutions 1810 E. Sahara Ave #100 Las Vegas, Nevada 89104
Reported: July 13, 2016 Initiated: December 15, 2015 #D-1142-2016
Product Description
Jenesis Capsules, 350 mg, 60-count bottles, Manufactured for Timeless Solutions 1810 E. Sahara Ave #100 Las Vegas, Nevada 89104
Reason for Recall
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 Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.
Details
- Recalling Firm
- Bee Extremely Amazed LLC
- Units Affected
- 79 bottles
- Distribution
- Nationwide
- Location
- Jewett, OH
Frequently Asked Questions
What product was recalled? ▼
Jenesis Capsules, 350 mg, 60-count bottles, Manufactured for Timeless Solutions 1810 E. Sahara Ave #100 Las Vegas, Nevada 89104. Recalled by Bee Extremely Amazed LLC. Units affected: 79 bottles.
Why was this product 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 Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 13, 2016. Severity: Critical. Recall number: D-1142-2016.
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