D-0314-2015 Class II Terminated
FDA drug recall D-0314-2015 was initiated by Chaotic Labz on November 14, 2014 and is designated Class II. 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. The recall status is terminated (terminated January 13, 2017). Affected quantity: 990 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- December 31, 2014
- Initiation Date
- November 14, 2014
- Termination Date
- January 13, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 990 bottles
Product Description
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 Pattern
Nationwide.
Code Information
Lot#: CLM061114, Exp 06/16