Recalls / Class I
Class ID-1149-2016
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
XCEL Capsules, 300 mg, 60-count bottles, Manufactured for JNS Health
- 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 fluoxetine, an FDA approved drug used to treat depression, anxiety, panic attacks, obsessive-compulsive disorder, or bulimia and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.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
- N/A
- 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-1149-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.