Status
Terminated
Drug Enforcement D-334-2013
Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs
Classification
Class I
Report Date
May 22, 2013
Termination Date
November 14, 2013
Product Information
- 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.
- Product quantity
- 213,000 capsules
- 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
- Recall initiation reason
- —
- Initial firm notification
- Telephone
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Performance Plus Marketing, Inc.
- Address
-
5560 E 61st St
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-334-2013
- Event ID
- 63916
- Recall initiation date
- December 17, 2012
- Center classification date
- May 16, 2013
- Code info
- 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.
- More code info
- —