D-1345-2014 Class I Terminated

Recalled by Tendex — Beverly Hills, CA

Recall Details

Product Type
Drugs
Report Date
May 28, 2014
Initiation Date
November 19, 2013
Termination Date
September 18, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
unknown

Product Description

P-BOOST Capsules Dietary Supplement 500 mg, supplied in 1 count blister pack and 5, 10, 20, and 40- count bottles, Distributed by P-Boost, Los Angeles, CA 900466

Reason for Recall

Marketed Without an Approved NDA/ANDA: FDA analysis found the product to contain undeclared active ingredient, tadalafil, thus making these products unapproved drugs.

Distribution Pattern

Nationwide.

Code Information

Lot # F51Q. EXP: 07/16 The UPC Codes for P-Boost are: 1ct - 862545101013 5ct - 862545101051 10ct - 862545101105 20ct - 862545101204 40ct - 862545101402