FDA recall D-231-2013

Palmer Natural Products · Class II · drug

Product

NOOTROPA COGNITIVE ENHANCEMENT SUPPLEMENT, 400 mg Aniracetam Capsules 60 count bottle, OTC Manufactured & Packaged in the USA for NOOTROPA.COM. DEVELOPED BY: Digital Superfuture Limited Arntel Building 9B 148 Des Voeux Rd. Hong Kong.

Reason for recall

Marketed Without an Approved NDA/ANDA: The products are unapproved drugs

Distribution

Florida, Idaho, California and Hong Kong. This product can be ordered on line.

Key facts

Status
Terminated
Initiation date
2013-03-11
Report date
2013-04-10
Termination date
2013-08-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
Star, ID, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-231-2013