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.

Recall Number D-333-2013

Classification Class I

Code Info 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.

Product Distributed Qty 686,000 capsules

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

Event Detail

Event Id 63916

Product Type Drugs

Status Ongoing

Recalling Firm Performance Plus Marketing, Inc., Commerce, CA, USA

Voluntary / Mandated Voluntary: Firm Initiated

Recall Initiation Date 2012-12-17

Initial Firm Notification of Consignee or Public Telephone

Distribution Pattern Nationwide