Indian God Lotion Spray Bottle, labeling is in foreign language
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
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.
What was recalled
Indian God Lotion Spray Bottle, labeling is in foreign language
- Recalling firm
- A&H Focal Inc.
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0553-2018
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
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