Recall Z-1530-2022 ยท MOL Condom, Synthetic
Family Dollar Stores, Llc.
SKYN ORIGINAL NON LATEX CONDOM 12CT, SKU 903409 LS SKYN NON LATEX LUBRICATED CONDOM 3CT, SKU 900794 SKYN ELITE NON LATEX CONDOM 12CT, SKU 903415
| 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 | 2877 total |
| Distribution | Product distributed to Family Dollar retail stores in US nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160399 | Skyn Original Polyisoprene Lubricated Male Condom Ansell Healthcare Products, LLC, Jul 25, 2016 |