Indian God Lotion Spray Bottle, labeling is in foreign language

Recall Number: D-0553-2018

Firm: A&H Focal Inc.

Classification: Class III

Status: Terminated

Report Date: 20180207

Initiation Date: 20170307

Termination Date: 20190614

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.

Indian God Lotion Spray Bottle, labeling is in foreign language