Drug product
BLUE Diamond PLATINUM Capsules, 1000 mg, supplied in 1, 5 and 10 count blister packs, Distributed By: DH Distribution Los Angeles, CA 90026 1 count blister UPC -608641933543; 5 count blister UPC - 608641932867; 10 count UPC -608641933536
D-335-2013
Product summary
- Event
- Event 63916
- Status
- Terminated
- Classification
- Class I
- Quantity
- 1,000 capsules.
- Official record key
drug-enforcement:D-335-2013
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# 01MNU0912, Exp: 08/15, (5 count) Lot# 05BD0712, Exp: 07/15 and 121781, Exp 01/14; (10 count) Lot # 05BD0712, Exp: 07/15
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