FDAClass IIMay 20, 2015

Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit recall: Sterility Concern

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…

Why was Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit recalled?

Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test.

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 #: 119814, Exp 05/31/2016

Product
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…
Recalling firm
Mission Pharmacal Co
Quantity
2,412 Kits
Distribution
Nationwide and Puerto Rico
Recall date
May 20, 2015
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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