BLUE Diamond PLATINUM Capsules, 1000 mg, supplied in 1, 5 and 10 count blister packs, Distributed...
FDA Recall #D-335-2013 — Class I — December 17, 2012
Product Description
BLUE Diamond PLATINUM Capsules, 1000 mg, supplied in 1, 5 and 10 count blister packs, Distributed By: DH Distribution Los Angeles, CA 90026 1 count blister UPC -608641933543; 5 count blister UPC - 608641932867; 10 count UPC -608641933536
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
1,000 capsules.
Distribution
Nationwide
Code Information
(1 count)Lot# 01MNU0912, Exp: 08/15, (5 count) Lot# 05BD0712, Exp: 07/15 and 121781, Exp 01/14; (10 count) Lot # 05BD0712, Exp: 07/15
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated