Sodium Sulfacetamide — Class III drug recall D-0817-2021
Terminated recall by Monarch PCM, LLC, reported 2021-09-29, distributed in OH, TN. Subpotency: one product for active ingredient assay and another one for preservative assay
| Recall number | D-0817-2021 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Monarch PCM, LLC, Fort Worth, TX, United States |
| Recall initiated | 2021-09-01 |
| Classified | 2021-09-20 |
| Reported by FDA | 2021-09-29 |
| Terminated | 2023-06-21 |
| Distributed | OH, TN |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 00342808103065, 00342808103126 |
| NDC | 42808-0103-06, 42808-0103-12 |
| Expiration dates | 2023-05 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0817-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.