FDA recall D-0972-2016

Product

Methyldrene Original 25 Ephedra ECA Stack Extra-Potent Fat Burner Dietary Supplement packaged in 100 capsule containers. Distributed by Cloma Pharma Laboratories, Samford, CT 06902.

Reason for recall

Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-08-24

Report date

2016-06-15

Termination date

2017-08-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Murray, UT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0972-2016