United StatesVarious Daye (Anne’s Day LTD) tampon products sold in the U.S. — including 9 Coated Super Tampons and 9 Nude Super Tampons (model FG-TMP-RET00090009), 9 Coated Regular and 9 Nude Regular Tampons (model FG-TMP-RET09000900), multiple refill and bundle packs, and dozens of other listed model and lot numbers (total 3,074 packs) — are being recalled. The products were recalled because they lack required FDA 510(k) clearance.
What's being recalled
9 Coated Super Tampons and 9 Nude Super Tampons; Model Number: FG-TMP-RET00090009;
9 Coated Regular Tampons and 9 Nude Regular Tampons; Model Number: FG-TMP-RET09000900;
18 Coated Regular Tampons; Model Number: FG-TMP-REF18000000;
18 Coated Super Tampons; Model Number: FG-TMP-REF00180000;
9 Coated Regular and 9 Coated Super Tampons; Model Number: FG-TMP-REF09090000;
9 Coated Regular and 9 Nude Regular Tampons; Model Number: FG-TMP-REF09000900;
9 Coated Super and 9 Nude Super Tampons; Model Number: FG-TMP-REF00090009;
Trial Tampon Box; Model Number: FG-TMP-REF04050504;
All in One Bundle; Model Number: FG-BNDL-PC-REFAIO;
Regular Flow Bundle; Model Number: FG-BNDL-PC-REFRF;
Heavy Flow Bundle; Model Number: FG-BNDL-PC-REFHF;
Refill 36 Coated Regular Tampons; Model Number: FG-TMP-MM-REF36000000;
Refill 36 Coated Super Tampons; Model Number: FG-TMP-MM-REF00360000;
Refill 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-MM-REF18180000;
Refill 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-REF18001800;
And 14 more products.
Recalling firm: Daye (Anne's Day LTD), London, N/A, United Kingdom.
How to identify it
Model Number: FG-TMP-RET00090009; UDI-DI: 05060994740608; Lot numbers: 20CR0014, 20CS0034, 20CS0037, 20CS0038, 20CS0039, 20CS0040, 20CS0041, CR001597, CR001598, CR001599, CR001616, CR001616NR001893, CR001617, CR001617CS002165, CR001617NR001844ST23/R/3001-0523ADL, CR001617NR001902, CR001619, CR001623, CR001625, CR001625NR001844ST23/R/3001-0523ADL, CR001626, CR001627, CR001629, CR001633, CR001636, CR001638, CR001640, CR001643, CR001645, CR001655, CR001661, CR001662, CR003000, CR003001, CR003002, CR003005, CR003008, CR003009, CR003020, CR003022, CR003027, CR003031, CR003032, CR003038, CS002088, CS002119, CS002120, CS002121, CS002122, CS002143, CS002144, CS002159, CS002164, CS002164NS001653, CS002165, CS002165NS001653, CS002166, CS002166NS001648ST23/M/3001-0223ADL, CS002167, CS002168, CS002169, CS002177, CS002181, CS002183, CS002195, CS002196, CS003005, CS003015, CS003016, CS003022, CS003034, CS003048, CS003049, CS003050, CS003052, CS003053, CS003054, CS003055, CS003057, CS003062, CS003081, CR001615, CR001616CS002163NR001890NS001649, CR001616CS002163NR001892NS001650, CR001616CS002164, CR001617CS002165, CR001655CS002196, CS002163, CS002164, CR001661NR002015, CS003005NS001775, CR003000, CS003005, CS003016, CS003022, CR003000, CR003000, CR003000NR002173, CS003022NS001781, Model Number: FG-TMP-RET09000900; UDI-DI: 05060994740592; Lot numbers: 20CR0014, 20CS0034, 20CS0037, 20CS0038, 20CS0039, 20CS0040, 20CS0041, CR001597, CR001598, CR001599, CR001616, CR001616NR001893, CR001617, CR001617CS002165, CR001617NR001844ST23/R/3001-0523ADL, CR001617NR001902, CR001619, CR001623, CR001625, CR001625NR001844ST23/R/3001-0523ADL, CR001626, CR001627, CR001629, CR001633, CR001636, CR001638, CR001640, CR001643, CR001645, CR001655, CR001661, CR001662, CR003000, CR003001, CR003002, CR003005, CR003008, CR003009, CR003020, CR003022, CR003027, CR003031, CR003032, CR003038, CS002088, CS002119, CS002120, CS002121, CS002122, CS002143, CS002144, CS002159, CS002164, CS002164NS001653, CS002165…
The hazard
Product lacks 510(k) clearance.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)