Safety Alerts & Recalls

What does this mean?

This recall for Selenium Sulfide Shampoo, 2.25%, 180 mL bottle from River's Edge Pharmaceuticals, LLC, and Harmony Labs, Inc. was issued at a warehouse and 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 take Selenium Sulfide Shampoo, 2.25%, and are concerned, you should follow up with your physician or pharmacist.

Recall of Select Lots of Selenium Sulfide Shampoo, 2.25%

River's Edge Pharmaceuticals, LLC and Harmony Labs, Inc. are recalling select lots of Selenium Sulfide Shampoo, 2.25%, 180 mL bottle, available by prescription only. The following lot numbers and expiration dates (Exp) are being recalled because the manufacturer failed to document the stability of the product: Lot numbers 94200, Exp 8/31/2010; F08B056, Exp 2/28/2010; F07K014, Exp 10/31/2009.

Selenium Sulfide Shampoo is used on the scalp to help control dandruff and dermatitis. Selenium is also available in other formulations including tablets and capsules, to be used for dietary supplementation. This recall alert only applies to the select lots of Selenium Sulfide Shampoo, 2.25%, 180 mL bottle. No other lots, strengths, formulations, or brands of selenium were involved in this recall.

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

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

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