A&H Focal Inc. recalls Indian God Lotion Spray Bottle, labeling is in foreign language
Recalled February 7, 2018 · FDA recall D-0553-2018 · A&H Focal
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. · FDA Class III
Units
unknown
Sold at
NY and NJ through six retail stores named "Asian Food Markets"
Description
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.
Product
Indian God Lotion Spray Bottle, labeling is in foreign language
Manufacturer(s)
A&H Focal Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →