Recall Z-1529-2022 ยท EMA Cement, Dental
Family Dollar Stores, Llc.
DENTEMP ONE STEP .077OZ, SKU 902139
| Date | Aug 17, 2022 (initiated Jun 23, 2022) |
| Status | Open, Classified |
| Reason | Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022. |
| Root 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 | 3122 |
| Distribution | Product distributed to Family Dollar retail stores in US nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964773 | DENTEMP ONE STEP Majestic Drug Co., Inc., Feb 21, 1997 |