D-334-2013 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
- 213,000 capsules
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
Distribution Pattern
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.