CASANOVA Capsules, 450 mg, MALE SEXUAL ENHANCER, supplied i n1 count blister packs, UPC 736211906...
FDA Recall #D-338-2013 — Class I — December 17, 2012
Product Description
CASANOVA Capsules, 450 mg, MALE SEXUAL ENHANCER, supplied i n1 count blister packs, UPC 736211906892; Distributed by: Casanova Distributors, Tucker, GA
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
96,000 capsules.
Distribution
Nationwide
Code Information
Lot# 030112, Exp: 03/15
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated