FDA-Device2025-11-05Class IIMISBRANDING

Initiation 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-MM-IB18180000;

FALSE CLAIMSNationwide distributiondevice
Hazard

Product lacks 510(k) clearance.

Who it affects
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
3074 packs
Manufactured in
Biscuit Factory Business Complex, 100 Drummond Road, London, N/A, United Kingdom
Products
Initiation 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-MM-IB18180000;

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0401-2026

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