Recalls / Class II
Class IID-234-2013
Product
Brain Defogger, Piracetam 390mg Choline 104mg capsules, 100 count bottle, OTC, BoostYourGrade, LLC, Orlando, FL. .
- Affected lot / code info
- All lot codes.
Why it was recalled
Marketed Without an Approved NDA/ANDA: The products are unapproved drugs
Recalling firm
- Firm
- Palmer Natural Products
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 11665 W State St, N/A, Star, Idaho 83669-5223
Distribution
- Quantity
- 4103 bottles
- Distribution pattern
- Florida, Idaho, California and Hong Kong. This product can be ordered on line.
Timeline
- Recall initiated
- 2013-03-11
- FDA classified
- 2013-04-01
- Posted by FDA
- 2013-04-10
- Terminated
- 2013-08-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-234-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.