FDA recall D-236-2013

Product

Oxiracetam & Choline , Oxiracetam 460mg Choline 110mg capsules a) 30 count bottle, b) 60 count bottle, c) 90 count bottle, OTC, BoostYourGrade, LLC, Orlando, FL. 32826

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-236-2013