FDA WARNING_LETTER - Walgreen Company - September 19, 2023

This FDA Warning Letter, dated September 12, 2023, addresses Walgreens regarding drug listing deficiencies for their product, Walgreens Sensitive Extra Whitening (NDC 0363-1588). The firm has failed to fulfill its listing obligations under section 510(j) of the FD&C Act, constituting a prohibited act under section 301(p), and rendering the product misbranded under section 502(o). Introduction of such a product into interstate commerce is prohibited under section 301(a). Specifically, the listing file submitted to FDA's eDRLS contains inaccuracies. The active ingredient list in the labeling (potassium nitrate and sodium fluoride) does not match the electronic listing file in SPL, which only includes sodium fluoride. Furthermore, the quantity or strength of the active moiety (fluoride ion) in the labeling ("0.15 gm in 100 gm") does not match the strength in the SPL ("0.24 g in 100 g"), which corresponds to sodium fluoride's strength, not fluoride ion's. These issues violate section 510(j)(1)(C) of the FD&C Act and 21 CFR 207.49(a)(4). FDA emphasizes that complete and accurate registration and listing data are crucial for patient safety, inspections, supply chain security, and post-market surveillance. The firm was previously notified of these deficiencies on December 6, 2022, and the product's data was removed from FDA's Online NDC Directory on January 20, 2023. Walgreens must investigate and correct all violations, including for other products, within 15 working days. Failure to comply may result in legal action, including seizure and injunction, and the deficient listing data will be inactivated.