Home / Recalls / Mission Pharmacal Co / D-1065-2015

D-1065-2015 Class II Terminated

Recalled by Mission Pharmacal Co — Boerne, TX

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
1,992 Kits

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.

Distribution Pattern

Nationwide and Puerto Rico

Code Information

Lot #: 526014, Exp. 05/31/2016

Other recalls by Mission Pharmacal Co

  • D-1064-2015 Class II — Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit, Rx Only, Sodium Sulfacetamide (April 30, 2015)
  • D-602-2013 Class III — Sodium Sulfacetamide 10% and Sulfur 5% Lotion, (NDC 42792-102-01), 25 g Manufact (January 23, 2013)