ClearanceBrief
Recall Z-0263-2024 ยท KOO Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt

Family Dollar Stores, Llc.

FIXODENT ORG CREAM 2.4OZ, SKU 906018 FIXODENT ADH CREAM WITH SCOPE 2OZ, SKU 906402 FIXODENT ORG CREAM TRAVEL .75OZ, SKU 901239

DateNov 7, 2023 (initiated Oct 4, 2023)
StatusOpen, Classified
ReasonProducts were stored outside of labeled temperature requirements.
Root causeStorage
ActionOn October 4, 2023, Family Dollar notified affected stores. Stores were instructed to check stock and quarantine and discontinue the sale of any affected product. Family Dollar's recall notice was posted online: https://www.familydollar.com/file/general/Posting%20for%20website%2010.6.23%20(2)[3].pdf Affected product was sold at these stores between June 1, 2023 and October 4, 2023. Customers who purchased affected product may return the product to the Family Dollar store where they were purchased without receipt. Customers with questions regarding this recall may contact Family Dollar Cus
Quantity329,044 total units
DistributionDistributed to Family Dollar stores in the following states: GA, AL, MS, FL, LA, AR, AZ, KS, TX, OK, CO, NM, NE, UT, NV, WY, ID, SD, ND, CA, MT, OR, WA.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K945200FIXODENT, FIXODENT FRESH, FASTEETH AND EXTRA HOLD FASTEETH DENTURE ADHESIVCES
Procter & Gamble Co., Nov 30, 1994