Drug product
MAYHEM capsules, Proprietary Blend 525 mg, Dietary Supplement, 60-count bottles, Chaotic-Labz, UPC 6 28586 67805 7.
D-0314-2015
Product summary
- Firm
- Chaotic Labz
- Event
- Event 69779
- Status
- Terminated
- Classification
- Class II
- Quantity
- 990 bottles
- Official record key
drug-enforcement:D-0314-2015
Official wording
Reason: Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared dexamethasone and cyproheptadine which are FDA approved drugs making this product an unapproved drug.
Code information: Lot#: CLM061114, Exp 06/16
Distribution pattern: Nationwide.
Derived failure modes
-
Unknown
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared dexamethasone and cyproheptadine which are FDA approved drugs making this product an unapproved drug.