Sodium Sulfacetamide 9% and Sulfur 4 — Class II drug recall D-1065-2015
Terminated recall by Mission Pharmacal Co, reported 2015-05-20, distributed nationwide. Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test.
| Recall number | D-1065-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mission Pharmacal Co, Boerne, TX, United States |
| Recall initiated | 2015-04-30 |
| Classified | 2015-05-11 |
| Reported by FDA | 2015-05-20 |
| Terminated | 2017-01-26 |
| Distributed | Nationwide (US) |
| Quantity | 1,992 kits |
| Reason classes | microbial contamination, sterility |
| NDC | 44523-0616-23 |
| Lot numbers | 526014 |
| Expiration dates | 2016-05-31 |
Product
Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit with Sunscreen, Rx Only, Sunscreen Broad Spectrum SPF 25, Net Wt. 3 oz (85 g), Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Net Wt. 16 oz (454 g), Manufactured for: BioComp Pharma Inc., San Antonio TX, 78230, NDC 44523-616-23
Reason for recall
Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test.
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-1065-2015. 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.