# FDA recall D-0817-2021

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

## Product

Sodium Sulfacetamide, 10%, Wash, packaged in bottles: a) 6 fl oz (177 mL) NDC 42808-103-06 UPC 3 42808 10306 5; b) 12 fl oz (354.8 mL) NDC 42808-103-12 UPC 3 42808 10312 6, Rx only, Manufactured in the U.S.A. for Exact-Rx, Inc., Melville, NY 11747

## Reason for recall

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

## Distribution

OH, TN

## Key facts

- **Recall number:** D-0817-2021
- **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-0817-2021

## Citation

> AI Analytics. FDA recall D-0817-2021. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-0817-2021. Source: US FDA. Licensed CC0.

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