Status
Terminated
Drug Enforcement D-333-2013
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
- libigrow XXXTREME Capsules, MAXIMUM STRENGTH FORMULA, 1000 mg, supplied in 1, 5 and 10 count blister packs, Distributed By Kretek International, Inc. Moorpark, CA 930210 1 count blister: UPC 705105830735, 5 count blister: UPC 610585435939, 10 count blister: UPC 610585435922.
- Product quantity
- 686,000 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-333-2013
- Event ID
- 63916
- Recall initiation date
- December 17, 2012
- Center classification date
- May 16, 2013
- Code info
- 1 count blister: Lot# 01MNU0912, Exp: 09/15; Lot# 01X0412-1, Exp: 04/15; Lot# 021647, Exp: 12/13, 5 count blister: Lot# 05X0412, Exp: 04/16, 10 count blister: Lot# 10X0412, Exp: 04/16; Lot# 10M0111, Exp: 01/14.
- More code info
- —