December 2012 FDA Recall Drug by P & J Trading Co
D-165-2013 - Marketed Without an Approved NDA/ANDA
This Class I drug recall was voluntarily initiated by P & J Trading Co on December 19, 2012 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed in Korea and the recall is currently terminated.
Recall Number: D-165-2013
Marketed Without an Approved NDA/ANDA: All lots of the dietary supplement Slimdia Revolution are being recalled because they contain sibutramine, a previously approved FDA drug removed from the U.S. marketplace for safety reasons, making it an unapproved new drug.
12-19-2012
02-27-2013
unknown
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
P & J Trading Co
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Korea
03-25-2013
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
SLIMDIA Revolution capsules, 30-count capsules per bottle, Yerba Naturals, 19685 Varda Ave., Buena Park, CA.
Batch or Lot Expiration Information
Lot# There are no manufacturing codes associated with the product.
