# FDA recall D-0557-2024

> **Denison Pharmaceuticals, LLC** · Class II · drug recall initiated 2024-05-28.

## Product

Little Remedies Gas Relief Drops (Simethicone/Antigas), packaged in 1 fl. oz. (30 mL) bottle with dropper, Dist by Medtech Products Inc., Tarrytown, NY 10591, NDC 63029-103-02

## Reason for recall

cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.

## Distribution

Recalled units were distributed to one customer. 100% recovered (113,544 units) and controlled at Denison Pharmaceuticals.

## Key facts

- **Recall number:** D-0557-2024
- **Recalling firm:** Denison Pharmaceuticals, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2024-05-28
- **Report date:** 2024-06-26
- **Termination date:** 2025-08-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lincoln, RI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0557-2024

## Citation

> AI Analytics. FDA recall D-0557-2024. Retrieved 2026-07-13 from https://api.ai-analytics.org/recall/D-0557-2024. Source: US FDA. Licensed CC0.

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