libigrow XXXTREME Capsules, MAXIMUM STRENGTH FORMULA, 1000 mg, supplied in 1, 5 and 10 count blis...
FDA Recall #D-333-2013 — Class I — December 17, 2012
Product Description
libigrow XXXTREME Capsules, MAXIMUM STRENGTH FORMULA, 1000 mg, supplied in 1, 5 and 10 count blister packs, Distributed By Kretek International, Inc. Moorpark, CA 930210 1 count blister: UPC 705105830735, 5 count blister: UPC 610585435939, 10 count blister: UPC 610585435922.
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
686,000 capsules
Distribution
Nationwide
Code Information
1 count blister: Lot# 01MNU0912, Exp: 09/15; Lot# 01X0412-1, Exp: 04/15; Lot# 021647, Exp: 12/13, 5 count blister: Lot# 05X0412, Exp: 04/16, 10 count blister: Lot# 10X0412, Exp: 04/16; Lot# 10M0111, Exp: 01/14.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated