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.”

Read the RAPS coverage

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