Drug product
libigrow capsules, PERFORMANCE ENHANCER, supplied in 1, 5 and 10 count blister packs, Distributed By: H & K Nutraceuticals Los Angeles, CA 1 count blister: UPC 094922567611, 5 count blister: UPC 094922567628, 10 count blister: UPC 610585434253.
D-332-2013
Product summary
- Event
- Event 63916
- Status
- Terminated
- Classification
- Class I
- Quantity
- 610,000 capsules
- Official record key
drug-enforcement:D-332-2013
Official wording
Reason: Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs
Code information: 1 count blister: Lot#: 791115, Exp: 12/13; Lot#: 01M0111, Exp: 01/14; Lot#: 01M0212-1, Exp: 02/15; Lot# 01M0212, Exp: 02/15; Lot# 01M0611-2, Exp: 06/14, 5 count blister: Lot# 05M0412, Exp: 04/16, 10 count blister: Lot# 10M0412, Exp: 04/16.
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs