# FDA recall D-0054-2022

> **First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy** · Class II · drug recall initiated 2021-08-13.

## Product

ACETYLCYSTEINE 2% OPTH SOLN, Rx only, Red Mountain Compounding Rx

## Reason for recall

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

## Distribution

494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.

## Key facts

- **Recall number:** D-0054-2022
- **Recalling firm:** First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-08-13
- **Report date:** 2021-11-03
- **Termination date:** 2023-04-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mesa, AZ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0054-2022

## Citation

> AI Analytics. FDA recall D-0054-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0054-2022. Source: US FDA. Licensed CC0.

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