Regulatory Focus™ > News Articles > Updated: FDA Warns OTC Drugmaker for Inaccurate Listing Information

Updated: FDA Warns OTC Drugmaker for Inaccurate Listing Information

Posted 06 June 2017 | By Michael Mezher 

Updated: FDA Warns OTC Drugmaker for Inaccurate Listing Information

Editor's note: this article was updated with comments from Prestige Brands Holdings.

The US Food and Drug Administration (FDA) on Thursday warned over-the-counter drugmaker Prestige Brands Holdings over missing information in the structured product labeling (SPL) submitted to FDA for two of the company's drugs.

According to agency, Prestige Brands' PediaCare Children's Plus Multi-Symptom Cold and Children's Plus Flu products contain phenylephrine hydrochloride, which is used as a nasal decongestant, as an active ingredient in the label provided to FDA.

However, FDA says the ingredient is missing from the SPL submitted to the agency for both drugs' listing files.

FDA says this omission constitutes a misbranding of the two products under Section 502(o) of the Federal Food Drug & Cosmetic Act (FD&C Act) and may result in consumers getting inaccurate information about the products.

"Information from your firm's registration and product listings are accessible not only to FDA, but to other interested parties, including consumers," FDA writes, noting that it has removed the two drugs from its National Drug Code (NDC) Directory until the listings are corrected.

In a statement sent to Focus on Wednesday, Phil Terpolilli, director of investor relations for Prestige Brands said that the erroneous listing was created before Prestige acquired the PediaCare brand, and that the company has since divested the brand and is no longer marketing the products. Terpolilli also said the company is in the process of updating the listings to include a marketing end date to signify the date on which the last batches of the drugs distributed by Prestige will expire.


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