D-332-2013 Class I Terminated

Recalled by Performance Plus Marketing, Inc. — Commerce, CA

Recall Details

Product Type
Drugs
Report Date
May 22, 2013
Initiation Date
December 17, 2012
Termination Date
November 14, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
610,000 capsules

Product Description

libigrow capsules, PERFORMANCE ENHANCER, supplied in 1, 5 and 10 count blister packs, Distributed By: H & K Nutraceuticals Los Angeles, CA 1 count blister: UPC 094922567611, 5 count blister: UPC 094922567628, 10 count blister: UPC 610585434253.

Reason for Recall

Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs

Distribution Pattern

Nationwide

Code Information

1 count blister: Lot#: 791115, Exp: 12/13; Lot#: 01M0111, Exp: 01/14; Lot#: 01M0212-1, Exp: 02/15; Lot# 01M0212, Exp: 02/15; Lot# 01M0611-2, Exp: 06/14, 5 count blister: Lot# 05M0412, Exp: 04/16, 10 count blister: Lot# 10M0412, Exp: 04/16.