FDA recall D-1169-2014

Product

Clalis capsules, 50 mg, 6 -count bottle ( labeling is in foreign language)

Reason for recall

Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined that the products was found to contain sildenafil, an undeclared active pharmaceutical ingredient.

Distribution

Nationwide and France

Key facts

Status

Terminated

Initiation date

2013-06-27

Report date

2014-03-26

Termination date

2019-10-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Ft Lauderdale, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1169-2014