PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: May 20, 2015 Initiated: April 30, 2015 #D-1065-2015

Product Description

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.

Details

Recalling Firm
Mission Pharmacal Co
Units Affected
1,992 Kits
Distribution
Nationwide and Puerto Rico
Location
Boerne, TX

Frequently Asked Questions

What product 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. Recalled by Mission Pharmacal Co. Units affected: 1,992 Kits.
Why was this product recalled?
Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 20, 2015. Severity: Moderate. Recall number: D-1065-2015.