Drug Distributor Warned for Drug Listing Errors

July 22, 2019

The FDA issued a warning letter to a Lancaster, New York-based drug distributor for errors in its OTC drug product listing information.

The agency first alerted American Sales Company, a distributor of pharmaceuticals and other products, in March over inaccurate listing information for its diphenhydramine hydrochloride and zinc acetate product, an anti-itching product. The deficiencies led the agency to consider the product misbranded and pull the product’s listing from the online National Drug Code (NDC) directory.

In the July 11 warning letter, the agency noted that the product’s labeling lists its active ingredient as diphenhydramine hydrochloride, but the NDC listing says the active ingredient is bromodiphenhydramine hydrochloride.

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