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U.S. Department of Health and Human Services

Enforcement Report - Week of May 28, 2014

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Product Detail

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
Recall Number D-1345-2014
Classification Class I
Code Info Lot # F51Q. EXP: 07/16 The UPC Codes for P-Boost are: 1ct - 862545101013 5ct - 862545101051 10ct - 862545101105 20ct - 862545101204 40ct - 862545101402
Product Distributed Qty unknown
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.

Event Detail

Event Id 66897
Product Type Drugs
Status Ongoing
Recalling Firm Tendex
City Beverly Hills
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-11-19
Initial Firm Notification of Consignee or Public Press Release
Distribution Pattern Nationwide.
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