# FDA recall D-0818-2021

> **Monarch PCM, LLC** · Class III · drug recall initiated 2021-09-01.

## Product

Hydroquinone, USP, 4% Skin Bleaching Cream, packaged in 1 oz (28.35g) tube, Rx only,  Manufactured for: Westminster Pharmaceuticals, LLC Nashville, TN 37217, NDC 69367-174-01 UPC 3 69367 17401 5

## Reason for recall

Subpotency: one product for active ingredient assay and another one for preservative assay

## Distribution

OH, TN

## Key facts

- **Recall number:** D-0818-2021
- **Recalling firm:** Monarch PCM, LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-09-01
- **Report date:** 2021-09-29
- **Termination date:** 2023-06-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Fort Worth, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0818-2021

## Citation

> AI Analytics. FDA recall D-0818-2021. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/D-0818-2021. Source: US FDA. Licensed CC0.

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