Sodium Sulfacetamide 9% and Sulfur 4 recalled over sterility concerns

Recall date

April 30, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Mission Pharmacal Co recalls Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit with Sunscreen, Rx Only, Sunscreen Broad Spectrum SPF 25, Net Wt. 3 oz…

Recall number

D-1065-2015

FDA classification

Class II

Brand / firm

Mission Pharmacal Co

Sold / distributed

Nationwide and Puerto Rico

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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