Class 2 Device Recall GS Denture Cleanser

• Date Initiated by Firm: June 23, 2022
• Date Posted: August 17, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1534-2022
• Recall Event ID: 90650
• Product Classification: Cleanser, denture, over the counter - Product Code EFT
• Product: GS DENTURE CLEANSER GRN TAB 40CT, SKU 906312 GS DENTURE CLEAN OVRNT TAB 40CT, SKU 906023
• Code Information: All product sold between May 1, 2022 - June 10, 2022.
• Recalling Firm/ Manufacturer: Family Dollar Stores, Llc.; 500 Volvo Pkwy; Chesapeake VA 23320-1604
• Manufacturer Reason for Recall: Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
• FDA Determined Cause: Storage
• Action: On June 23, 2022, the firm notified affected Family Dollar retail stores via an urgent Pull and Hold notice, effective June 24, 2022. Retail stores were informed that due to a shipping issue, the affected products could not be sold. Stores were instructed to remove affected products from the sales floor and quarantine them. https://www.familydollar.com/file/general/Voluntary_Recall_of_Certain_Over_the_Counter_Products_080522.pdf
• Quantity in Commerce: 869
• Distribution: Product distributed to Family Dollar retail stores in US nationwide.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.