Drug product
Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit, Rx Only, Sodium Sulfacetamide 9% and Sulfur 4.5% Wash, Net Wt. 16 oz (454 g), Daily Moisturizing Wash, 16 fl. oz. (473 mL), Manufactured for: BioComp Pharma Inc., San Antonio, TX 78230, NDC 44523-0609-23
D-1064-2015
Product summary
- Event
- Event 71072
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,412 Kits
- Official record key
drug-enforcement:D-1064-2015
Official wording
Reason: Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test.
Code information: Lot #: 119814, Exp 05/31/2016
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Microbial contamination
Microbial Contamination