FDAClass IIIJune 26, 2013

Sodium Sulfacetamide 10% and Sulfur 5% recall: Superpotent

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

Why was Sodium Sulfacetamide 10% and Sulfur 5% recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot# E112, Exp 05/14 Lot# J062, Exp 09/14

Product
Sodium Sulfacetamide 10% and Sulfur 5% Lotion, (NDC 42792-102-01), 25 g Manufactured for: Austin Pharmaceuticals, LLC, Wilmington, DE
Recalling firm
Mission Pharmacal Co
Quantity
8,437 bottles
Distribution
Nationwide
Recall date
June 26, 2013
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls