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Pharmaceuticals / Submissions and Approvals

FDA Warns Drugmaker for Inaccurate API Listing

May 4, 2017
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The FDA warned drug manufacturer Exact-RX over failure to accurately list its APIs.

Listing information for Exact-RX’s Sodium Sulfacetamide and Sulfer 10%/5% Cleanser omitted sulfur, the agency found.

Instead, the listing included Ferrous Cation as an ingredient, which contravenes the API information in the product labeling.

The FDA removed the product’s listing information from its Online NDC Directory until the firm takes corrective action.

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