Drug product
Mojo nights Capsules, Male Sexual Enhancer, supplied in 1 and 5 count blister packs, Distributed By: Mojo Health, Pompano Beach, FL I count blister UPC - 718122119738; 5 count blister UPC - 705105836430;
D-336-2013
Product summary
- Event
- Event 63916
- Status
- Terminated
- Classification
- Class I
- Quantity
- 219,000 capsules.
- Official record key
drug-enforcement:D-336-2013
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) Lot# 01MJ0712, (1 count) 01MM0211 Exp: 07/15; (5 count) Lot# 05M0912, Exp: 10/15;
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