A&H Focal Inc. recalls Indian God Lotion Spray Bottle, labeling is in foreign language

Recall date

March 7, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0553-2018

FDA classification

Class III

Brand / firm

A&H Focal Inc.

Sold / distributed

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

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Indian God Lotion Spray Bottle, labeling is in foreign language