FDA Warns OTC Manufacturer After Finding Inaccurate Information in Product Listings

June 13, 2017

On Thursday, June 1st, the FDA issued a Warning Letter to Prestige Brands Holdings, an over-the-counter (OTC) drug manufacturer.  PediaCare Children’s Plus Multi-Symptom Cold and PediaCare Children’s Plus Flu, two products manufactured by the company, were the subject of the recent Warning Letter.  In the letter, FDA states that a recent review of listing information provided for the products revealed inaccurate information included in the labeling.

According to FDA’s letter, the Agency’s “review of the listings for the products PediaCare Children’s Plus Multi-Symptom Cold, NDC 52183-385, and PediaCare Children’s Plus Flu, NDC 52183-365, reveals that while the active ingredient, Phenylephrine Hydrochloride appears on the copy of the label provided with the listing for each product, it is missing from the listing information in Structured Product Labeling (SPL) submitted for both drug listing files.”

Section 510(j) of the Federal Food, Drug, & Cosmetic (FD&C) Act outlines the requirements governing the registration and listing of drug products.  According to this legislation, the listings for these products are required to include “the name and quantity of each active pharmaceutical ingredient.”  FDA notes that Prestige Brands Holdings has failed to fulfill these requirements, “which is a prohibited act under Section 301(p) of the FD&C Act, [21 U.S.C. 331(p)].”  Additionally, FDA states that the company’s “failure to fulfill its listing obligations misbrands the product under Section 502(o) of the FD&C Act [21 U.S.C. 352(o)],” which is prohibited under Section 301(a) [21 U.S.C. 331(a)].

Both the FDA and other interested parties (i.e., consumers) have access to product registration and listing information, making it increasingly more important that the information included within these is accurate.  FDA has removed the listing data for these two products from its online NDC Directory and will not be replacing it until the necessary corrections are made.  FDA states that it is taking this action in “an effort to maintain a correct and accurate database in order to protect and promote the public health.”

Upon receipt of the letter, Prestige Brands Holdings was given 15 working days to notify the Agency of the specific steps being taken to correct the violations.  An explanation of each step being taken to prevent the recurrence of violations and copies of supporting documentation should also be included in the company’s response.  If the company is not able to correct the violations within this time frame, it should still respond, explaining its reason for the delay and the date by which it will have completed the corrections.

For additional information on the violations, view FDA’s Warning Letter.

Do you have an FDA-regulated product that you want to ensure is compliant with all requirements and regulations?  Have you recently received or are you at risk of receiving a Warning Letter from the FDA? Do you want to avoid being in this type of situation?  Regardless of your current needs, our quality & compliance group can help you overcome any obstacles and/or avoid possibly disastrous circumstances.  To learn more about how we can help you, contact us today.


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