FDA recall D-1346-2014

Tendex · Class I · drug

Product

NATURECT Capsules Dietary Supplement 500 mg, supplied in 1 count blister pack and 5, 10, 20, and 40- count bottles, Distributed by P-Boost, Los Angeles, CA 900466

Reason for recall

Marketed Without an Approved NDA/ANDA: FDA analysis found the product to contain undeclared active ingredient, tadalafil, thus making these products unapproved drugs.

Distribution

Nationwide.

Key facts

Status: Terminated
Initiation date: 2013-11-19
Report date: 2014-05-28
Termination date: 2014-09-18
Voluntary/Mandated: Voluntary: Firm initiated
Location: Beverly Hills, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1346-2014