FDA Recall D-1138-2016
Bee Extremely Amazed LLC · Jewett, OH
Class I — life-threatening Terminated 1591 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Asset BOLD Capsules, 500 mg, 60-count bottles, Distributed by Descor, LLC www.assetcapsules4u.com
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 Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.
Recall record
- Recall number
D-1138-2016- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution
- Nationwide
- Recall initiated
- 2015-12-15
- Classified by FDA Center
- 2016-07-06
- FDA published
- 2016-07-13
- Terminated
- 2020-04-23
- Recalling firm
- Bee Extremely Amazed LLC
- Firm location
- Jewett, OH