FDA Drug recall D-0553-2018
Indian God Lotion Spray Bottle, labeling is in foreign language
- FDA Drug
- Class III
- terminated
- Published 2018-02-07
On 2018-02-07 the FDA classified a Class III recall of Indian God Lotion Spray Bottle, labeling is in foreign language by A And H Focal, citing 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, maki….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0553-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-03-07 |
| Published | 2018-02-07 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | A And H Focal |
| Distribution | NJ, NY |
Product
Indian God Lotion Spray Bottle, labeling is in foreign language
Reason
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.
Identifiers
| code_info | All Lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0553-2018%22
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