PlainRecalls
FDA Drug Low Class III Terminated

Sodium Sulfacetamide 10% and Sulfur 5% Lotion, (NDC 42792-102-01), 25 g Manufactured for: Austin Pharmaceuticals, LLC, Wilmington, DE

Reported: June 26, 2013 Initiated: January 23, 2013 #D-602-2013

Product Description

Sodium Sulfacetamide 10% and Sulfur 5% Lotion, (NDC 42792-102-01), 25 g Manufactured for: Austin Pharmaceuticals, LLC, Wilmington, DE

Reason for Recall

Superpotent: Drug product active ingredients were formulated incorrectly (too high) with respect to the label strength.

Details

Recalling Firm
Mission Pharmacal Co
Units Affected
8,437 bottles
Distribution
Nationwide
Location
Boerne, TX

Frequently Asked Questions

What product was recalled?
Sodium Sulfacetamide 10% and Sulfur 5% Lotion, (NDC 42792-102-01), 25 g Manufactured for: Austin Pharmaceuticals, LLC, Wilmington, DE. Recalled by Mission Pharmacal Co. Units affected: 8,437 bottles.
Why was this product recalled?
Superpotent: Drug product active ingredients were formulated incorrectly (too high) with respect to the label strength.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 26, 2013. Severity: Low. Recall number: D-602-2013.