Over-the-Counter / Packaging

FDA Warns Guangdong for API Label Mix-Up

Nov 09, 2017

RAPS

The U.S. FDA issued a warning letter to China-based Guangdong Zhanjiang Jimin Pharmaceutical Co. after finding that one of the company’s over-the-counter drugs had a label listing an incorrect active pharmaceutical ingredient.

According to the label on Guangdong’s Piyanping Anti-Itch Lotion, the product contains hydrocortisone 1% as its active ingredient, when in fact, the active ingredient is dexamethasone acetate.

The manufacturer told the FDA that the labelling issue was the result of "a translation mistake.”

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