Drug product
Super-DMZ Rx 2.0 Capsules, 60 count bottles, Dietary Supplement, Lean muscle mass, hardness and strength, Manufactured for Blackstone Labs Boca Raton, FL 33433.
D-1150-2014
Product summary
- Event
- Event 65772
- Status
- Terminated
- Classification
- Class I
- Quantity
- 11,200 bottles (60 capsules per bottle) (quantities for E07Q unknown)
- Official record key
drug-enforcement:D-1150-2014
Official wording
Reason: Marketed without an Approved NDA/ANDA; product contains the steroid ingredient 2, 17a-dimethyl-17b-hydroxy-5a-androst-1-en-3-one, making it an unapproved new drug
Code information: lot numbers: 1) M55Q (A) Exp 04/2016, 2) M55Q (2) Exp 05/16, 3)E07Q Exp unknown
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Marketed without an Approved NDA/ANDA; product contains the steroid ingredient 2, 17a-dimethyl-17b-hydroxy-5a-androst-1-en-3-one, making it an unapproved new drug