# FDA recall D-0553-2018

> **A&H Focal Inc.** · Class III · drug recall initiated 2017-03-07.

## Product

Indian God Lotion Spray Bottle, labeling is in foreign language

## Reason for recall

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.

## Distribution

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

## Key facts

- **Recall number:** D-0553-2018
- **Recalling firm:** A&H Focal Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-03-07
- **Report date:** 2018-02-07
- **Termination date:** 2019-06-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Staten Island, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0553-2018

## Citation

> AI Analytics. FDA recall D-0553-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0553-2018. Source: US FDA. Licensed CC0.

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