FDA recall D-0553-2018

Product

Indian God Lotion Spray Bottle, labeling is in foreign language

Reason for recall

Marked Without An Approved NDA/ANDA: FDA analysis found this product to contain diethyl phthalate, an inactive ingredient in several modified release solid oral dosage forms, making this product unapproved drug for which safety and efficacy have not been establish and therefore, subject to recall.

Distribution

NY and NJ through six retail stores named "Asian Food Markets"

Key facts

Status

Terminated

Initiation date

2017-03-07

Report date

2018-02-07

Termination date

2019-06-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Staten Island, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0553-2018