FIXODENT ORG CREAM 2.4OZ, SKU 906018 FIXODENT ADH CREAM WITH SCOPE 2OZ, SKU 906402 FIXODENT ORG CREAM TRAVEL .75OZ, SKU
FDA device recall Z-0263-2024 · posted 2023-11-07 · Open, Classified
Recall details
- Recalling firm
- Family Dollar Stores, Llc.
- Reason for recall
- Products were stored outside of labeled temperature requirements.
- Action taken
- On 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 Customer Service at 844-636-7687 between 9 a.m. and 5 p.m. EST. Customers should contact their physician or health care provider if they have experienced any problems that may be related to using these products.
- Root cause
- Storage
- Status
- Open, Classified
- Product code
- KOO
- Quantity affected
- 329,044 total units
- Distribution
- Distributed 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.
- Date initiated
- 2023-10-04
- Date posted
- 2023-11-07
- Location
- Chesapeake, VA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FIXODENT, FIXODENT FRESH, FASTEETH AND EXTRA HOLD FASTEETH DENTURE ADHESIVCES (K945200) | Procter & Gamble Co. | 1994-11-30 |