FDA recall D-0971-2016

Product

Black Widow 25 Ephedra Super 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-0971-2016