# FDA recall D-0292-2022

> **Efficient Laboratories, Inc.** · Class II · drug recall initiated 2021-08-24.

## Product

Rompe Pecho Ex Expectorant,  packaged in a) 4 Fl. Oz. (118 mL) bottles NDC 58593-829-04 and b) 6 Fl. Oz. (178 mL) bottles NDC 58593-829-06, Distributed by Efficient Laboratories, Inc. Miami, FL 33166

## Reason for recall

Microbial Contamination of Non-Sterile Products

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0292-2022
- **Recalling firm:** Efficient Laboratories, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-08-24
- **Report date:** 2021-12-29
- **Termination date:** 2022-12-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Miami, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0292-2022

## Citation

> AI Analytics. FDA recall D-0292-2022. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/D-0292-2022. Source: US FDA. Licensed CC0.

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