D-335-2013 Class I Terminated
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
- 1,000 capsules.
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
Distribution Pattern
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