BLUE Diamond Pill, supplied in 1, 5 and 10 count blister packs, Male Sexual Enhancement, Distribu...

FDA Recall #D-334-2013 — Class I — December 17, 2012

Recall #D-334-2013 Date: December 17, 2012 Classification: Class I Status: Terminated

Product Description

BLUE Diamond Pill, supplied in 1, 5 and 10 count blister packs, Male Sexual Enhancement, Distributed By: DH Distribution Los Angeles, CA 90026. 1 count blister: UPC 705105524764, 5 count blister: UPC 736211124012, 10 count blister: UPC 736211123916.

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

213,000 capsules

Distribution

Nationwide

Code Information

1 count blister: Lot# 01M0412, Exp: 04/15, and Lot#91782, Exp: 01/14. 5 count blister: Lot# 05M0412, Exp: 04/15; 10 count blister: Lot# 10M0412, Exp: 04/15.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated