Procter & Gamble Manufactura S. de R.L. de C.V.

Warning LetterOpen

United StatesFEI 3004444900Issued Mar 14, 2023Center for Drug Evaluation and Research | CDER

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3004444900.

Violations1

Issue DateMar 14, 2023

Product TypeDrugs

StatusOpen

Letter Details

Firm: Procter & Gamble Manufactura S. de R.L. de C.V.
Location: United States
FEI Number: 3004444900
Country: United States
Issue Date: March 14, 2023
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

Procter & Gamble Manufactura S. de R.L. de C.V. was cited for contradictory drug listing information for Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion (NDC 58933-541), violating Section 510(j) of the FD&C Act and 21 CFR Part 207. The company submitted mismatched active ingredients between the product's labeling and the electronic listing file (SPL) submitted to FDA's Drug Registration and Listing System, with the active ingredients listed on the Drug Facts label not matching those in the electronic submission. Following an initial deficiency letter in October 2022 and a data removal notification in December 2022, the product's data was removed from FDA's Online NDC Directory due to the company's failure to correct these discrepancies.

Procter & Gamble Manufactura S. de R.L. de C.V. FDA Warning Letter, March 14, 2023