libigrow capsules, PERFORMANCE ENHANCER, supplied in 1, 5 and 10 count blister packs, Distributed...
FDA Recall #D-332-2013 — Class I — December 17, 2012
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
Recalling Firm
Performance Plus Marketing, Inc. — Commerce, CA
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
610,000 capsules
Distribution
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.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated