FDA-Device2025-11-05Class IIMISBRANDING

Initiation 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-IB18001800;

FALSE CLAIMSNationwide distributionMedical devices
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Hazard

Product lacks 510(k) clearance.

Intended for
Adults (13 years to 66.7 years)
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 Nude Regular Tampons; Model Number: FG-TMP-MM-IB18001800;

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0402-2026

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