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
D-1065-2015
Product summary
- Event
- Event 71072
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,992 Kits
- Official record key
drug-enforcement:D-1065-2015
Official wording
Reason: Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test.
Code information: Lot #: 526014, Exp. 05/31/2016
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Microbial contamination
Microbial Contamination