FDA-Drug2018-02-07Class III

Indian God Lotion Spray Bottle, labeling is in foreign language

A&H Focal Inc.
Hazard

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.

Sold states
NY and NJ through six retail stores named "Asian Food Markets"
Affected count
unknown
Manufactured in
119 Linwood Ave, Staten Island, NY, United States
Products
Indian God Lotion Spray Bottle, labeling is in foreign language

Official notice

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

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