DENTEMP ONE STEP .077OZ, SKU 902139
FDA device recall Z-1529-2022 · posted 2022-08-17 · Open, Classified
Recall details
- Recalling firm
- Family Dollar Stores, Llc.
- Reason for recall
- Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
- Action taken
- 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
- Root cause
- Storage
- Status
- Open, Classified
- Product code
- EMA
- Quantity affected
- 3122
- Distribution
- Product distributed to Family Dollar retail stores in US nationwide.
- Date initiated
- 2022-06-23
- Date posted
- 2022-08-17
- Location
- Chesapeake, VA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DENTEMP ONE STEP (K964773) | Majestic Drug Co., Inc. | 1997-02-21 |