Saturday, March 04, 2023 6:28:03 PM
SOHM had tweeted it on April 22.
The letter also says that the company said their CMO went out of business. SOHM is in business, so I was 100% sure it is a different company.
Letter says:
• You use a CMO, (b)(4), to manufacture Hydroquinone USP 4% Skin Bleaching Cream. Your CMO released batch (b)(4) to you on November 16, 2020. You distributed this batch to numerous customers. During the inspection you were unable to provide adequate stability data for your batch and formulation.
• You use a CMO, (b)(4) to manufacture the following products:
o Hydroquinone USP 4% Skin Bleaching Cream
o Sodium Sulfacetamide 10% & Sulfur 5% Cleanser
o Sodium Sulfacetamide 10% and Sulfur 2% Cleanser
o Sodium Sulfacetamide 9.8% and Sulfur 4.8% Cleanser
o Selenium Sulfide 2.25% Shampoo"
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