Safety Alerts & Recalls

What does this mean?

This recall for Rosaderm Cleanser packaged in 6 oz. and 12 oz. tubes from River's Edge Pharmaceuticals, LLC and Harmony Labs, Inc. was issued at a warehouse/pharmacy level only. The FDA and companies involved have determined that any recalled product that may have been dispensed to patients does not pose a significant health risk. If you use Rosaderm Cleanser and are concerned, you should follow up with your doctor.

Recall of Select Lots of Rosaderm Cleanser

River's Edge Pharmaceuticals, LLC and Harmony Labs, Inc. are recalling several lots of Rosaderm Cleanser (Sodium Sulfacetamide 10%/Sulfur 5%), packaged in 6 oz. and 12 oz. tubes. The recall was issued because the manufacturer did not verify the packaging before they distributed the products in these lots: Rosaderm Cleanser 6 oz., Lot numbers: 15400, 15600, 88100, 88200, F08A056, F08A060, and F08C064

Rosaderm Cleanser 12 oz., Lot numbers: 88000 and F07K075

Rosaderm Cleanser contains the active ingredients sulfacetamide sodium with sulfur and is used in the treatment of acne. This recall alert only applies to the select lots of the generic Rosaderm Cleanser. No other sulfacetamide sodium with sulfur products were involved in this recall.

To view the FDA notice about this recall, please visit: [more information here

Source: FDA
Publication Date: 2010-04-12
Last Updated: 2010-04-13
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