Recall Z-0265-2024 ยท EMA Cement, Dental
Family Dollar Stores, Llc.
DENTEMP ONE STEP .077OZ, SKU 902139
| Date | Nov 7, 2023 (initiated Oct 4, 2023) |
| Status | Open, Classified |
| Reason | Products were stored outside of labeled temperature requirements. |
| Root cause | Storage |
| Action | 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 Cus |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964773 | DENTEMP ONE STEP Majestic Drug Co., Inc., Feb 21, 1997 |