FDA recall D-1065-2015

Mission Pharmacal Co · Class II · drug

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.

Distribution

Nationwide and Puerto Rico

Key facts

Status: Terminated
Initiation date: 2015-04-30
Report date: 2015-05-20
Termination date: 2017-01-26
Voluntary/Mandated: Voluntary: Firm initiated
Location: Boerne, TX, United States

Primary source

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