FDA recall D-0314-2015

Chaotic Labz · Class II · drug

Product

MAYHEM capsules, Proprietary Blend 525 mg, Dietary Supplement, 60-count bottles, Chaotic-Labz, UPC 6 28586 67805 7.

Reason for recall

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.

Distribution

Nationwide.

Key facts

Status
Terminated
Initiation date
2014-11-14
Report date
2014-12-31
Termination date
2017-01-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Atkins, AR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0314-2015