P-BOOST Capsules Dietary Supplement 500 mg, supplied in 1 count blister pack and 5, 10, 20, and 4...
FDA Recall #D-1345-2014 — Class I — November 19, 2013
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.
Recalling Firm
Tendex — Beverly Hills, CA
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
unknown
Distribution
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated