FDA Drug recall D-0817-2021
Sodium Sulfacetamide, 10%, Wash, packaged in bottles: a) 6 fl oz (177 mL) NDC 42808-103-06 UPC 3 42808 10306 5
- FDA Drug
- Class III
- terminated
- Published 2021-09-29
On 2021-09-29 the FDA classified a Class III recall of Sodium Sulfacetamide, 10%, Wash, packaged in bottles: a) 6 fl oz (177 mL) NDC 42808-103-06 UPC 3 42808 10306 5 by Monarch Pcm, citing subpotency: one product for active ingredient assay and another one for preservative assay.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0817-2021 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2021-09-01 |
| Published | 2021-09-29 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Monarch Pcm |
| Distribution | OH, TN |
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
Subpotency: one product for active ingredient assay and another one for preservative assay
Identifiers
| upc | 342808103065 |
|---|---|
| upc | 342808103126 |
| code_info | Lots: a) 21FP1737 Exp 05/2023; b) 21FP1738 Exp 05/2023 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0817-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.