FDA-Drug2015-05-20Class II

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

Mission Pharmacal Co
Hazard

Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test.

Sold states
Nationwide and Puerto Rico
Affected count
1,992 Kits
Manufactured in
38505 IH-10 West, N/A, Boerne, TX, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1065-2015

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