# FDA recall D-0989-2022

> **Grato Holdings, Inc.** · Class II · drug recall initiated 2022-05-24.

## Product

Homeopathic EarAche Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: RITE AID, 30 Hunter Lane, Camp Hill, PA 17011. NDC 11822-3644-3

## Reason for recall

Microbial contamination of non-sterile product.

## Distribution

Nationwide within the USA

## Key facts

- **Recall number:** D-0989-2022
- **Recalling firm:** Grato Holdings, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-05-24
- **Report date:** 2022-06-15
- **Termination date:** 2023-06-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Woodbine, IA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0989-2022

## Citation

> AI Analytics. FDA recall D-0989-2022. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-0989-2022. Source: US FDA. Licensed CC0.

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