FDA recall D-1149-2016

Product

XCEL Capsules, 300 mg, 60-count bottles, Manufactured for JNS Health

Reason for recall

Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared fluoxetine, an FDA approved drug used to treat depression, anxiety, panic attacks, obsessive-compulsive disorder, or bulimia and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-12-15

Report date

2016-07-13

Termination date

2020-04-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Jewett, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1149-2016