D-1064-2015 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 20, 2015
- Initiation Date
- April 30, 2015
- Termination Date
- January 26, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,412 Kits
Product Description
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
Reason for Recall
Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test.
Distribution Pattern
Nationwide and Puerto Rico
Code Information
Lot #: 119814, Exp 05/31/2016