D-333-2013 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
686,000 capsules

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

Distribution Pattern

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.