FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Warns Compounder for Labeling Violations

May 14, 2019
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The FDA issued a warning letter to ABC Compounding  in Morrow, Georgia for inaccurate listing information for its antiseptic hand wash.

The agency noted that the compounder’s over-the-counter Santi Wash antiseptic hand wash, an iodine-based sanitizer, contained an inconsistency in its active ingredient statement. The electronic listing file identified the active ingredient as povidone-iodine 5 mg in 1 ml, while the Drug Facts labeling identified it as benzethonium chloride USP 0.2 percent.

“Our review revealed that the listing for this product includes inaccurate information,” the agency said. The agency deemed the product to be misbranded because of the labeling violation.

The FDA first alerted ABC Compounding about the problem in a November 2018 letter and removed the listing data from the online NDC directory at the end of the year.

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