Product Recalls

SKU 9249038 REMEDY PHY HYDRAGRD BRR 4OZ/UPC 88827770378

Medline Industries, LP contract manufacturer is recalling specific lots of Medline Remedy Specialized Silicone Cream 4 oz tubes within expiry. This recall is being initiated as a result of out-of-specification (“OOS”) test results identified by Medline’s contract manufacturer. The first such OOS result is a stability failure, specifically, preservative efficacy testing (“PET”) failures at initial (time zero). The other results pertained to two OOSs for aldehyde limits in raw material used in the manufacture of Medline Remedy Specialized Silicone Cream. Use of this product may pose a risk of skin irritation or infection and could result in dermal exposure to aldehyde compounds, which may have adverse effects at elevated levels, including irritation, inflammation, or damage of the skin, including the eyes, nose, and throat, if applied on the face. All affected product is to be returned to Medline for credit.