FDA recall D-1349-2016

Product

CROCODILE BILE PILL FOR ASTHMA, packaged in 100-count bottles within a box, remaining labeling contains Chinese characters.

Reason for recall

Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2016-04-20

Report date

2016-07-20

Termination date

2018-06-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Brooklyn, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1349-2016