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

FDA recall notice · announced June 26, 2013 · Mission Pharmacal Co

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

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.

Notes

Distribution: Nationwide
Lot/code information: Lot# E112, Exp 05/14 Lot# J062, Exp 09/14
Quantity: 8,437 bottles
Status: Terminated
Products in this recall event:
- Sodium Sulfacetamide 10% and Sulfur 5% Lotion, (NDC 42792-102-01), 25 g Manufactured for: Austin Pharmaceuticals, LLC, Wilmington, DE (D-602-2013)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.